Measures for the Administration of Drug Registration 2005

The Measures for the Administration of Drug Registration were deliberated and adopted at the executive meeting of the State Food and Drug Administration. They are hereby promulgated and shall be implemented as of May 1, 2005.

Measures for the Administration of Drug Registration

Chapter I. General Provisions

Article 1 For the purposes of guaranteeing the safety, effectiveness and quality controllability of drugs and regulating the drug registration, these Measures are formulated in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law) and the Regulation on the Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Regulation on the Implementation of the Drug Administration Law).

Article 2 These Measures shall apply to the application for drug clinical trials, drug production or import, as well as the relevant drug registration, inspection, supervision and administration undertaken within the People’s Republic of China.

Article 3 The drug registration refers to the examination and approval process during which the State Food and Drug Administration (hereinafter referred to as the SFDA) conducts, at the drug registration application filed by an applicant, a systematic evaluation of the safety, effectiveness and quality controllability of the drug to be marketed and makes the decision on whether or not to approve the application in accordance with the statutory procedures.

Article 4 The state encourages the study and development of new drugs, and employs the system of expedite examination and approval to new drugs developed, new drugs for treating complicated and serious diseases as well as the drugs badly needed for emergencies.

Article 5 The State Food and Drug Administration shall be in charge of the administration of drug registration throughout the country, and be responsible for the examination and approval of drug clinical trial, drug manufacturing and import.

The (food) drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government shall verify the research and development as well as the conditions, examine the completeness, standardization and authenticity of the application materials for drug registration, and organize a test of trial samples.

Article 6 An applicant for drug registration (hereinafter referred to as the applicant) refers to an institution that files an application for drug registration, bears the corresponding legal liabilities, and holds the drug approval certification documents after the application is approved.

A domestic applicant shall be an institution that is lawfully registered within China and can bear civil liabilities independently, while an overseas applicant is a lawful overseas drug manufacturer. Where an overseas applicant applies for the registration of drug import, its office based in China or an agency within China entrusted thereby shall go through the formalities for the registration of the imported drugs.

The personnel handling the applications for drug registration shall be professionals in corresponding fields, and shall be home with the laws and regulations and technical requirements for the administration of drug registration.

Chapter II Application for Drug Registration

Article 7 The applications for drug registration shall include the applications for new drugs, applications for drugs for which there are already state standards, applications for imported drugs and supplementary applications thereof. For a domestic applicant, the procedures for filing applications for new drug and for filing applications for drugs with existing state standards shall be followed; for an overseas applicant, the procedures for the application for imported drugs shall be followed.

Article 8 The “applications for new drugs” shall refer to the applications for the registration of drugs that haven’t been marketed within China. If the type of preparation or the route of administration of any drugs that have been marketed is changed, or if the range of indications thereof is newly expanded, the said drugs shall be treated as new drugs.

The applications for drugs with existing state standards shall refer to the applications for the registration of the drugs for which the SFDA has promulgated formal standards.

The applications for imported drugs shall refer to the applications for registration of the drugs that are manufactured overseas and marketed in China.

The supplementary applications shall refer to the applications for changing, adding or canceling the originally approved matters or contents after the applications for new drugs, drugs with existing state standards or imported drugs have been approved.

Article 9 An applicant shall file an application for drug registration with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and shall submit relevant materials and drug samples. In the case of an application for registration of imported drugs, the applicant shall file the application with the SFDA.

The applicant shall be responsible for the genuineness of all the contents of the application materials.

Article 10 If two or more entities, as a joint applicant, apply for the registration of a new drug, they shall file an application with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise is located. If all the applicant entities are drug-manufacturing enterprises, they shall file an application with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise that applies for the preparation is located. If none of the applicant entities is a drug manufacturing enterprise, they shall file an application with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where the samples are trial-produced.

Article 11 For the drug applied for registration or the prescription, techniques or uses of the drug, the applicant shall provide its patent or the patent of any other person in China as well as the explanations on its ownership; if any patent of any other person exists within China, the applicant shall submit a statement of no infringement upon the patent of others.

Article 12 Where any dispute arises after the application for drug registration is approved, the parties concerned shall settle the dispute through negotiation by themselves, or through the patent administrative department or the people’s court pursuant to the relevant laws and regulations.

A patentee may, on the basis of the final ruling made by the patent administrative department or valid judgment affirming infringement as made by the people’s court, file with the SFDA for canceling the registered approval number of the drug. Accordingly, the SFDA shall write off the drug approval certification documents of the infringer.

Article 13 As for a drug of which the Chinese patent has been obtained by any other person, an applicant may file a registration application within 2 years before the expiration of the patent of that drug. The SFDA shall conduct an examination pursuant to these Measures, and, if the applicant meets the relevant conditions, it shall issue to it the registered number of drug approval, an Imported Drug Registration Certificate or the Pharmaceutical Product Registration Certificate after the patent expires.

Article 14 Where a producer or seller, who has obtained a permit to produce or sell an drug containing any new chemical ingredient, submits any undisclosed experimental data or other data obtained by itself, the SFDA shall not, within 6 years after it grants this permit, approve any other application for using the undisclosed data unless it is consented to by the applicant who has obtained the aforesaid permit, unless the data submitted by the other applicant is obtained by itself.

Chapter III Pre-clinical trial of New Drugs

Article 15 The pre-clinical trial of new drugs for applying for drug registration shall include synthetic techniques, extraction methods, physical and chemical properties, purity, choice of form of this drug, selection of prescriptions, preparation techniques, inspection methods, quality indicators, stability, pharmacology, toxicology, nuclein animal dynamics, etc. As for Chinese traditional medicine preparations, the sources and processing of the original medicine materials, etc. shall also be included; as for biologic products, the sources, quality standards, preservation conditions, biological features, inheritance stability and immunological study of the primary raw materials such as microbial and toxic species, cell line or organism, etc. shall also be included.

Article 16 The relevant administrative provisions shall be executed in the pre-clinical trial of new drugs, and the Criterions for the Quality Control of Non-clinical Study of Drugs must be executed in the safety evaluation study.

Article 17 An institution engaging in drug study and development must have the personnel, site, equipment, instruments and management system that can meet the requirements for the experiment and study projects. The animals, reagents, and raw materials for experiment use shall conform to the relevant provisions and requirements of the state, and shall ensure the authenticity of all the experiment data and materials.

Article 18 As to a separate application for the registration of a drug preparation, the applicant shall have, for the raw material medicines used for the study of the drug preparation, the registered number of drug approval, an Imported Drugs Registration Certificate or Pharmaceutical Product Registration Certificate, and the raw material medicines must be obtained through legal channels. If, for the raw material medicines, the applicant does not have the registered number of drug approval, an Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate, such applicant shall be subject to the approval of the SFDA.

Article 19 Where an applicant entrusts any other institution to conduct drug study, separate experiment, testing, trial manufacturing or production of samples etc, it shall enter into a contract with the trustee. The applicant shall be responsible for the authenticity of the drug study data in the application materials.

Article 20 If the application materials for drug registration include any drug experiment and study materials submitted by any overseas drug study institution, there must be attached with the explanations produced by that overseas drug study institution on the projects and the page numbers of the materials provided, and the certifications which can prove that the institution has been legally registered and notarized overseas, and the attached materials may be used as the application materials unless they have been acknowledged by the SFDA. The SFDA shall send personnel to make on-spot inspection where necessary.

Article 21 When inspecting drug study according to the needs, the SFDA and the (food) drug administration of a province, autonomous region or municipality directly under the Central Government may request the applicant or the drug study institution undertaking the experiment to conduct an experiment again according to the projects, methods and data specified in the application materials, and shall send personnel to oversee the experiment on the spot; or an institute for drug control or other drug study institution may be entrusted to make an experiment again.

Article 22 The pre-clinical study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SFDA. Where an applicant adopts other evaluation methods and techniques in the experiment, it shall submit the materials that can prove their scientificness.

Chapter IV. Clinical Trial of Drugs

Section 1 Basic Requirements

Article 23 The clinical trial of drugs (including bioequivalence experiments) shall be subject to the approval of the SFDA and shall follow the Criterions for the Quality Control of Clinical Trials of Drugs.

Article 24 An applicant shall conduct clinical trials when applying for the registration of a new drug.

The clinical trials are classified into four phases: I, II, III and IV. Before a new drug is approved for marketing, phases I, II, and III clinical trials shall be conducted. Under certain circumstances, the applicant may, upon approval, only conduct phases II and III clinical trials or only phase III clinical trials.

The phase I clinical trials: the preliminary trials on clinical pharmacology and human body safety evaluation, which aim to observe the degree of tolerance of human body against the new drug and the drug dynamics, and provide the basis for working out the dosage administration scheme.

The phase II clinical trials: the preliminary evaluation of the treating effects, which aim to preliminarily evaluate the treating effect and safety of the drug on the target patients with the applicable disease, and also to provide the basis for the determination of study design and dosage administration scheme for the clinical trial in phase III. Various methods may be employed for the study design of this phase in light of the specific study purpose, including the randomized controlled trial.

The phase III clinical trials: the confirmation phase of the treating effect, which aim to further verify the treating effect and safety of the drug on the target patient with the applicable disease, to evaluate the relationship between interest and risk, and to eventually provide adequate basis for the examination of the drug registration application. Generally, the trials shall be randomly controlled ones with sufficient samples.

The phase IV clinical trials: the phase of application study conducted by the applicant independently after the new drug comes into the market, which aim to examine the curative effect of the drug and the adverse reactions when it is widely used, to evaluate the relationship between interest and risk when the drug is used in ordinary or special groups and to improve the dosage administration, etc.

Article 25 Generally speaking, it is not required to conduct any clinical trial for the registration of drugs with existing state standards. Among those, which require a clinical trial, a bioequivalence trial shall be conducted for chemical drugs. For a drug whose quality needs to be controlled by techniques and standards, clinical trials shall be conducted. In a supplementary application, the applicant shall conduct clinical trials if new indications are added for any drug already on the market or if the manufacturing techniques of the drug are altered significantly.

The bioequivalence trial is, under the same testing conditions, to compare the statistical disparities of the absorption extent and speed of the active substances of the identical dosage or of different dosages of the same drug in the human body through the approach of bio-availability study and by considering the parameters of drug dynamics as the indicators.

Article 26 The number of cases experimented in drug clinical trials shall be in line with the purpose of the drug clinical trials, shall meet the relevant statistical requirements and shall not be less than the minimum clinical trial case number as specified in these Measures. As for a rare disease, special disease or any other circumstance where it is needed to reduce clinical trial cases or to exempt the clinical trial, the examination and approval of the SFDA is required.

Article 27 With respect to the bacteria or other special drugs prepared during the phase of selecting bacteria or virus species, if it is unable to evaluate the curative effect thereof due to lack of suitable animal model and laboratory, the applicant may apply for clinical trial with the SFDA on the precondition that the safety of the experimented person is secured.

Section 2 Requirements Before Trial

Article 28 After a drug clinical trial has been approved, the applicant shall select, from the institutions qualified for drug clinical trials, an institution to undertake the drug clinical trial, decide through consultation the entity responsible for the clinical trial, the major researchers and the entities participating in the clinical trial.

Article 29 The applicant shall conclude a clinical trial contract with the selected entity responsible for and the entities participating in the clinical trial, provide the researchers with manuals, and together with the researchers, design and perfect the clinical trial scheme by referring to the relevant technical guiding principles.

The clinical trial scheme shall be subject to the examination of the ethic committee of the clinical trial institution.

Article 30 The applicant shall provide the selected clinical trial entities with free medicines for clinical trial use and drugs for comparison use (except for clinical trials in phase IV), to which it shall attach a sample inspection report, and bear the expenses needed for the clinical trial.

Article 31 The drugs for clinical trial use shall be produced and prepared in workshops meeting the conditions as provided for in the Criterions for the Quality Control of Drug Manufacturing. The process of production and preparation shall strictly follow the Criterions for the Quality Control of Drug Manufacturing.

The SFDA or the entrusted (food) drug administration of the province, autonomous region or municipality directly under the Central Government may conduct on-the-spot checks where it so requires.

Article 32 An applicant may inspect the drugs for clinical trial use by itself according to the drug standards determined by the SFDA, or entrust an institute to do the drug control as specified in Articles 147 and 148 to conduct the inspection. The drugs shall not be used in clinical trial unless they have passed the drug inspection.

The SFDA may designate an institute for drug control to make a selective inspection over the drugs for clinical trial use.

The vaccine products, blood products, and other biological products as well as overseas-manufactured drugs for clinical trial use as provided for by the SFDA, shall be subject to the inspection by the institutes for drug control designated by the SFDA. They shall not be used in the clinical trial unless they have passed the aforesaid drug inspection.

The applicant shall be liable for the quality of the drugs for clinical trial use.

Article 33 An applicant shall, before carrying out the clinical trial of a drug, submit the clinical trial scheme and the names of the principal researchers of the entity responsible for the clinical trial, the list of the participating entities and the researchers thereof, the letter of approval of the ethics committee, the sample of the letter of consent and knowledge to the SFDA for record, and shall submit copies of the aforesaid materials to the (food) drug administrations of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical trial entities are located and where the application is accepted.

Section 3 Administration of Clinical Trials

Article 34 In the course of clinical trial of a drug, the applicant shall appoint a supervisor to supervise the course of trial in pursuance of the Criterions for the Quality Control of Clinical Trial of Drugs.

Article 35 If the applicant finds out that any clinical researcher violates the relevant provisions or fails to carry out the clinical trial scheme, it shall urge the researcher to make corrections; if the circumstances are serious, it may demand suspension or termination of the clinical trial, and shall report the relevant situation to the SFDA and the (food) drug administration of the relevant province, autonomous region or municipality directly under the Central Government.

Article 36 After finishing each phase of clinical trial, the applicant shall submit a clinical trial and statistical analysis report to the SFDA and to the (food) drug administration of the relevant province, autonomous region or municipality directly under the Central Government. Moreover, after it finishes the clinical trial in phase IV, it shall submit a summary report to the SFDA.

If the period of clinical trial exceeds 1 year, the applicant shall submit a report on the progress of the clinical trial to the SFDA and the (food) drug administration of the relevant province, autonomous region or municipality directly under the Central Government every year as of the date of approval.

Article 37 The clinical trials of a drug shall be carried out within 3 years from the date of approval. If it fails to be carried out within that period, the original certifications of approval shall be invalidated automatically. A new application shall be filed if it is still needed to carry out clinical trials.

Article 38 The entities and personnel participating in the clinical trials shall be familiar with the nature, functions, curative effect and safety of the drugs for clinical trial use, shall understand the responsibilities and obligations of clinical researchers, shall obtain the letter of consent and knowledge voluntarily signed by the experimented person, and shall make clinical trial records genuinely, accurately, completely, timely and truthfully.

Article 39 If any applicant violates the Criterions for the Quality Control of Clinical Trial of Drugs or requests for changing the data or conclusion of the trial, the entities and personnel participating in the clinical trial shall report it to the (food) drug administration of the relevant province, autonomous region, or municipality directly under the Central Government and the SFDA.

Article 40 The entities undertaking the clinical trials and the clinical researchers are obliged to take necessary measures to guarantee the safety of the experimented person.
The clinical researchers shall pay close attention to the occurrence of any adverse reaction case involving the drugs for clinical trial use, take proper treating measures for the experimented person without delay, and shall make records.
If any serious adverse reaction case occurs in the course of a clinical trial, the researchers shall, within 24 hours, report it to the (food) drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SFDA, and shall timely report it to the ethics committee.

Article 41 The SFDA and the (food) drug administrations of the relevant provinces, autonomous regions and municipalities directly under the Central Government shall conduct supervision and inspection over the clinical trials that have been approved.

Article 42 If any of the following cases occurs in the course of a clinical trial, the SFDA may request the applicant to modify the clinical trial scheme, or to suspend or terminate the clinical trial:
(1) The ethics committee fails to fulfill its duties;
(2) The safety of the experimented person can’t be effectively guaranteed;
(3) A serious adverse reaction case fails to be reported within the prescribed time limit;
(4) No report on the progress of clinical trial is submitted in a timely and truthfully manner;
(5) The approved clinical trial fails to produce evaluation results within 2 years after the scheduled end of the study;
(6) There is, already, evidence proving that the drugs for clinical trial use are ineffective;
(7) The drugs for clinical trial use encounter quality problems;
(8) Frauds are committed in the clinical trial; or
(9) Other cases of violation of the Criterions for the Quality Control of Clinical Trial of Drugs.

Article 43 Where the applicant or the clinical trial entity is ordered by the SFDA to modify the clinical trial scheme, to suspend or terminate the clinical trial, it shall comply with such order.

Article 44 If a wide range of unanticipated adverse reactions or serious adverse reaction cases occur in a clinical trial, or there has been evidence that can prove the drugs for clinical trial use have serious quality problems, the SFDA or the (food) drug administration of the relevant province, autonomous region or municipality directly under the Central Government may take urgent measures and order the applicant and the clinical trial entity to suspend or terminate the clinical trial, and the applicant and the clinical trial entity shall stop the clinical trial immediately.

Article 45 The clinical researchers shall be responsible for the use of drugs for clinical trial use. The researches shall ensure that all the drugs for study use are only used on the experimented persons, and the method of use and dosage shall conform to the study scheme. No researcher may use the drugs for trial use to any person not participating in the clinical trial. The drugs for clinical trial use shall not be sold.

Article 46 If any overseas applicant wishes to conduct an international multi-center clinical trial of drugs, it shall file an application with the SFDA pursuant to these Measures and meet the requirements of the following provisions:
(1) The drugs for clinical trial use shall be those that have been registered overseas or have entered into the phase II or III clinical trial. The SFDA shall not accept any application filed by an overseas applicant for international multi-center clinical trial of the new preventive vaccine drugs that have not yet been registered overseas;
(2) The SFDA may, when granting approval for conducting an international multi-center clinical trial of any drug, request the applicant to carry out Phase I clinical trial in China where it so requires;
(3) When conducting an international multi-center clinical trial of any drug in China, if any serious adverse reactions and unanticipated adverse reactions relating to such drugs are found in any country, the applicant shall timely report to the SFDA pursuant to the relevant provisions;
(4) After a clinical trial is ended, the applicant shall submit a complete clinical trial report to the SFDA;
(5)If the data obtained in an international multi-center clinical trial of drugs is used in the application for drug registration in China, the provisions relating to clinical trial provided for in the Drug Administration Law, the Implementation Regulations, and these Measures shall be met, and the applicant shall submit all the study materials of the international multi-center clinical trial.

Chapter V. Application and Examination & Approval of New Drugs

Section 1 Basic Requirements

Article 47 The materials submitted for the registration of new drugs shall be complete and normative, and the data must be true and reliable. The documentary materials quoted shall be marked with the title of the article, title of the publication, as well as the volume, issue and page number, etc. The documentary materials not publicly published shall be accompanied with the certification documents about the owners’ permit to use. The materials in foreign languages shall be accompanied with Chinese translations pursuant to the requirements.

Article 48 With respect to the applications for the following new drugs, the SFDA shall make an expedite examination and approval:
(1)The effective components extracted from the plants, animals, minerals and other materials that haven’t been marketed within China and the preparations thereof, the newly found drug materials and preparations thereof;
(2)The chemical raw material medicines as well as the preparations and biological products thereof that haven’t been approved for marketing home and abroad;
(3)The new drugs that are used in treating AIDS, malignant tumours and rare diseases etc;
(4)New drugs treating the diseases that can’t be cured by effective means yet; and
(5)The Drugs badly needed in an emergent accident.

Article 49 The (food) drug administration of a province, autonomous region and municipality directly under the Central Government shall, after receiving an application for registration of any new drug listed in Article 48 of these Measures, conduct an examination and give opinions on whether or not that application meets the conditions for expedite examination and approval. The SFDA shall decide whether or not to make an expedite examination and approval after it receives the materials and opinions submitted by the aforesaid (food) drug administration of a province, autonomous region and municipality directly under the Central Government.

Article 50 With regard to a new drug jointly developed by several entities, the application for registration of the new drug may be filed by one of these entities and no repetitive application may be filed by any other entity. Except for the drugs listed in Items (1) and (2) of Article 48 of these Measures, each category of such drug may, after the application for registration of the new drug is approved, be manufactured by one entity only, and different specifications of the same category may not be manufactured by different entities.

With regard to the technologies of a new drug, it is not allowed to incite different applicants to file their respective application, or to file repetitive applications in any disguised form. Where necessary, the SFDA and the relevant (food) and drug administration of the province, autonomous region and municipality directly under the Central Government may verify the relevant information. If it is found true upon verification, the repetitive application shall be rejected. If the repetitive applications have accepted, they shall be disapproved.

Article 51 In the examination process of a new drug, the registration category of and the technical requirements for the new drug shall remain unchanged even if the preparation of identical active ingredients is permitted to enter the overseas market.

In the examination process of a new drug, the registration category of and the technical requirements for the new drug shall remain unchanged even if the preparation of identical active ingredients applied by a domestic drug production enterprise is allowed to enter the market of China.

Section 2 Examination & Approval of Clinical Trial of New Drugs

Article 52 After finishing the pre-clinical trial of new drugs, an applicant shall fill in the Application Form for Drug Registration, and faithfully submit the relevant materials and drug samples to the local (food) drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 53 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall examine the application materials. If the application materials meet the relevant requirements, it shall accept them and shall give the applicant an application acceptance notice. If they don’t meet the relevant requirements, it shall give the applicant an application rejection notice and make an explanation.

The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall, within 5 days from the day when it accepts an application, organize an on-spot inspection over the drug research and production information as well as the conditions thereof, take 1-3 samples for inspection use, and send a notice about the registration inspection to the designated institute for drug control. The administration of the province, autonomous region or municipality directly under the Central Government shall, within the prescribed time limit, submit the examination opinions, inspection report and application materials to the SFDA, and notify the applicant.

Article 54 The institute for drug control receiving the notice about registration inspection shall check and test the above-mentioned samples, verify the drug standards of the application, and submit the inspection report and verification opinions to the SFDA within the prescribed time limit, and simultaneously send copies of those documents to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government that sent it the inspection notice, and to the applicant as well.

Article 55 After the SFDA receives the application materials, it shall organize technicians of pharmacology, iatrology and other subjects to conduct technical evaluation of the new drug. If it believes that the applicant meets the pertinent provisions, it shall issue it an Approval of Drug Clinical Trial; if it believes that it doesn’t meet the pertinent provisions, it shall give it a Notice of Examination Opinions and make an explanation.

Article 56 If, after the applicant receives the verification opinions, the institute for drug control considers that the drug standards applied for are unable to control the quality, the applicant may withdraw the new drug application. If the applicant fails to withdraw its application and if the SFDA considers that the drug standards are really unable to control the quality, the application shall be disapproved.

Article 57 If, upon inspection, any sample doesn’t conform to the drug standards for which the applicant applies, the SFDA shall disapprove the new drug application.

Article 58 During the period of the SFDA’s examining an application for registration of a drug, except for the creative ingredients of the drug or new discoveries involving the drug safety and the supplementary materials as required, the applicant shall generally not supplement any new technical materials. If the applicant insists that it must supplement some technical materials, it shall withdraw its drug registration application and shall file a new one after it has prepared a complete set of materials.

Article 59 Where a new drug application is withdrawn by the applicant on its own initiative or disapproved by the SFDA, if the applicant meets the conditions for application as provided for in the present Measures after it conducts a new study, and there is no identical product entering into the new drug monitoring period, it may file a new application and go through the original application formalities.

Section 3 Manufacturing Examination & Approval of New Drugs

Article 60 After finishing the clinical trial of drugs, an applicant shall fill out an Application Form for Drug Registration, shall submit the clinical trial materials and other modified and supplemented materials to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, explain the basis and reasons in details, and send the raw materials of the standard products to the National Institute for the Control of Pharmaceutical and Biological Products at the same time.

Article 61 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall conduct a formal examination over the application materials. If it considers that the application materials meet the relevant requirements, it shall accept them and issue to the applicant a notification of acceptance of the drug registration application. If it considers that the application materials don’t meet the relevant requirements, it shall reject them and issue to the applicant a notice of rejection of the drug registration application and make an explanation.

Article 62 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall, within 5 days from the day when it accepts an application, organize an on-the-spot inspection over the manufacturing process and conditions. It shall select samples from the products of 3 successive production batch numbers, send a registration inspection notice to the designated institute for drug control, and submit the examination opinions, investigation report and application materials to the SFDA within the prescribed time limit, and notify the applicant.

Article 63 The samples from the products of 3 successive batch numbers needed for the new drug application shall be manufactured in the workshops with the certificate of Criterions for the Quality Control of Drug Manufacturing. For newly initiated drug manufacturing enterprises, newly established drug manufacturing workshops of drug manufacturing enterprises, or newly added types of preparations to be manufactured, the manufacturing process of samples thereof must conform to the requirements of the Criterions for the Quality Control of Drug Manufacturing.

Article 64 An institute for drug control receiving the registration inspection notice shall make an inspection over the selected samples, and submit an inspection report to the SFDA within the prescribed time limit, and at the same time send a copy to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where the inspection is conducted, and to the applicant.

Article 65 After receiving the application materials, the SFDA shall make an overall review of the them and may demand the applicant to make supplements. If it considers that the application materials meet the relevant requirements, it shall issue the applicant an Approval Document on Drug Registration and a New Drug Certificate. If the applicant holds a License for Drug Manufacturing and have the conditions for manufacturing the drug, the SFDA may simultaneously issue to the applicant the registered number of drug approval. If SFDA considers that the application materials don’t meet the relevant requirements, it shall issue to the applicant a Notice about the Examination Opinions and make an explanation.

Article 66 The drug specifications shall be offered by the applicant, but which shall be subject to the verification and approval of the SFDA according to the application materials submitted by the applicant. When an approval is granted to the drug application, the drug specifications and registration standard shall be announced simultaneously. The applicant shall be responsible for the correctness and accuracy of the drug specifications.

A drug manufacturing enterprise shall track the safety and effectiveness of the drug after it enters into the market, and it shall file an application for modifying the drug specifications without delay if necessary.

The drug specifications shall be printed and produced according to the content as approved and the format as required by the SFDA.

Article 67 Where, to apply for a new drug, the samples from the products of 3 successive batch numbers are manufactured in the workshops with the License for Drug Manufacturing and the Criterions for the Quality Control of Drug Manufacturing, they may be marketed within their effective periods after passing the inspection conducted by the institute for drug control as designated by the SFDA and obtaining the registered number of drug approval in accordance with Articles 147 and 148 of the present Measures.

Section 4 Administration of the Monitoring Periods of New Drugs

Article 68 With a view to protecting public health, the SFDA may set forth monitoring periods for new drugs approved to be manufactured, to continually monitor the safety of those new drugs.

The SFDA will not approve other enterprises to manufacture or import new drugs within the monitoring periods.

Article 69 The monitoring period of a new drug shall be determined on the basis of the existing safety research materials and the research status at home and abroad. It shall not exceed 5 years by calculating from the date of approval of manufacturing the drug.

Article 70 For a new drug within the monitoring period, the drug manufacturing enterprise shall regularly inspect the manufacturing techniques, quality, stability, curative effect and adverse reactions, etc., and make a report each year to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

Where any of the entities relating to the manufacturing, operation, use, or inspection or supervision of drugs finds that the new drug has any serious quality problem, or causes any serious or unanticipated adverse reactions, it shall report, without delay, to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 71 With respect to a new drug with any serious quality problem, or causing serious or unanticipated adverse reactions, the (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall organize an investigation immediately and report it to the SFDA.

Article 72 If the drug manufacturing enterprise fails to perform the duties during the new drug monitoring period, it shall be ordered to make corrections by the (food) drug administration of the province, autonomous region or municipality directly under the Central Government

Article 73 If a new drug, for which the monitoring period has been set, has not been manufactured within 2 years from the day of approval, the SFDA may approve the applications for manufacturing that new drug filed by other drug manufacturing enterprises and continue to monitor the new drug.

Article 74 Where the SFDA has already approved any other applicant’s clinical trial of drugs before a new drug enters into the monitoring period, such application may continue to be handled pursuant to the procedures for the application, examination and approval of drug registration. If the application conforms to the relevant provisions, the SFDA may approve the manufacturing or import of the drug and monitor it together with such new drug manufactured by domestic drug manufacturing enterprises.

Article 75 From the day when a new drug enters the monitoring period, no identical registration application filed by any other applicant may be accepted. If the SFDA has already accepted an application of any other applicant but not yet permitted this other applicant to conduct drug clinical trials, such application shall be returned to the applicant. After the monitoring period of such new drug ends, the applicant may file an application for the registration of the drug with existing state standards or for the import of drug.

Article 76 After an application for the registration of an imported drug is approved, if the domestic applicant has already been granted an approval to conduct clinical trials, the application may continue to be handled pursuant to the procedures for application, examination and approval of drug registration. The SFDA may approve the manufacturing of the drug if the requirements are met. The applicant may also withdraw that application and file a new application for registration of drugs with existing state standards. If the application for the clinical trial of the same drug filed by any other applicant has been accepted but not yet approved, such application shall be returned to the applicant, but the applicant may file a new application pursuant to the requirements for the registration of a drug with existing state standards.

Section 5. Transfer of New Drug Technologies

Article 77 The “transfer of new drug technologies” refer to the act that the holder of a new drug certificate transfers the manufacturing technologies of the new drug to a drug manufacturing enterprise, and the latter files an application for the manufacturing of that new drug.

Article 78 The “transferor of new drug technologies” refers to the holder of a new drug certificate. If it has obtained the registered number of drug approval, it shall file an application for writing off the original registered number of drug approval when applying for transferring the new drug technologies.

Article 79 The new drug technologies shall be transferred to a drug manufacturing enterprise once and for all. If the said drug manufacturing enterprise can’t manufacture the drug due to any special reasons, the holder of the new drug certificate may transfer the new drug technologies for a second time upon the strength of the contract by which the original transferee abandons the manufacturing of that new drug, or other relevant certification documents, etc. The SFDA shall write off the registered number of approval for the new drug of the original transferee pursuant to the provisions.

The enterprise accepting the transferred new drug technologies may not retransfer such technologies any more.

Article 80 A drug manufacturing enterprise accepting the transferred new drug technologies shall have obtained a License for Drug Manufacturing and a certificate of the Criterions for the Quality Control of Drug Manufacturing. The new drug to be transferred shall fall within the manufacturing scope as specified in the License for Drug Manufacturing and the certificate of the Criterions for the Quality Control of Drug Manufacturing of the transferee.

With regard to a newly established drug manufacturing enterprise, or a drug production enterprise that has newly built a drug manufacturing workshop or has newly added a type of drug preparation, after it obtains the License for Drug Manufacturing that specifies the corresponding manufacturing scope, it may file an application for transferring the new drug technologies. After it obtains the registered number of drug approval, it shall, within the time limit as specified in Article 6 of the Regulation on the Implementation of the Pharmaceutical Administration Law, a certificate of the Criterions for the Quality Control of Drug Manufacturing that specifies the corresponding certification scope. Prior to the obtainment of such a certificate, the drug under the registered number of approval shall not be marketed.

Article 81 When transferring the new drug manufacturing technologies, the holder of the new drug certificate shall sign a transfer contract with the transferee, and shall transfer all the technologies and materials to the transferee and guide the manufacturing of the latter, on a trial basis, for 3 successive batches of qualified products.

Article 82 With respect to a new drug jointly developed by several entities, the transfer of new drug technologies shall be proposed by the entities that jointly signed the new drug certificate and a transfer contract shall be concluded.

Article 83 When transferring the new drug technologies, the holder of the new drug certificate and the transferee shall jointly file an application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the transferee is located, fill in the Drug Supplementary Application Form, and submit the relevant materials with an attachment of the transfer contract.

Article 84 After accepting an application for the transfer of new drug technologies, the drug administration of the province, autonomous region or municipality directly under the Central Government shall verify and check the spot of trial manufacturing, manufacturing equipment, manufacturing of samples and inspection records of the transferee, select samples and notify the institute for drug control to conduct an inspection.

Article 85 The institute for drug control undertaking the drug inspection shall finish the inspection within the prescribed time limit, work out an inspection report and submit it to the drug administration of the province, autonomous region or municipality directly under the Central Government which notified it to make the inspection.

Article 86 The drug administration of the province, autonomous region or municipality directly under the Central Government shall examine the inspection report and relevant materials received by it and put forward examination opinions thereon, submit them to the SFDA and notify the applicant.

Article 87 The SFDA shall make a comprehensive evaluation of the supplementary application for the transfer of new drug technologies. If it considers that it is necessary to conduct clinical trials, it shall issue to the applicant an Approval Document on Drug Clinical Trials.

The applicant shall, after finishing the clinical trials, submit the clinical study materials to the SFDA.

Article 88 If the SFDA considers that the supplementary application for the transfer of new drug technologies meets the relevant provisions, it shall issue an Approval Document on the Drug Supplementary Application and registered number of drug approval, and it shall simultaneously write off the Drug approval certificate that has already been obtained by the transferor. If it considers that the aforesaid supplementary application doesn’t conform to the relevant provisions, it shall issue a Notice about the Examination Opinions and make an explanation.

Article 89 With regard to a new drug within its monitoring period, no application for the transfer of the technologies of the new drug may be accepted. After the expiration of the monitoring period of the new drug, the applicant may file a registration application according to requirements for the drug with existing state standards.

Chapter VI. Application and Examination & Approval of Drugs with Existing State Standards

Article 90 To apply for manufacturing a drug with existing state standards, the applicant shall be a drug manufacturing enterprise with a License for Drug Manufacturing and with a certificate of Criterions for the Quality Control of Drug Manufacturing. The drug for which the application is filed shall be in line with the manufacturing scope and certification scope as specified in the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing.

Article 91 If a License for Drug Manufacturing, which specifies the corresponding manufacturing scope, has been obtained for a newly launched drug manufacturing enterprise, for a newly established drug manufacturing workshop of a drug manufacturing enterprise, or for the newly added form of preparation, a drug registration application may be filed.

Article 92 After an applicant has finished the trial manufacturing pursuant to the relevant technical requirements, it shall fill out an Application Form for Drug Registration, and submit the relevant materials and drug samples to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

Article 93 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall conduct a formal examination over the application materials. It shall accept them if they meet the relevant requirements, and it shall issue to the applicant a notice about the acceptance of drug registration application. If it considers that the application materials don’t meet the relevant requirements, it shall reject them and issue to the applicant a notice about the rejection of the drug registration application and shall make an explanation.

The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall, within 5 working days from the day when it accepts an application, organize an on-spot inspection over the manufacturing process and conditions, select samples from the products of 3 successive batch numbers and give the designated institute for drug control a sample inspection notice. It shall examine the application materials within the prescribed time limit, put forward its examination opinions, submit the examination opinions and application materials to the SFDA, and notify the applicant simultaneously.

Article 94 An institute for drug control receiving the notice on registration inspection shall conduct an inspection on the selected samples, and send a drug registration inspection report to the SFDA within the prescribed time limit, and simultaneously send a copy to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government, which gave it an inspection notice, and to the applicant as well.

Article 95 The SFDA shall examine the examination opinions and application materials. Where necessary, it may demand the applicant to make supplements. If it believes that it is necessary to conduct clinical trials, it shall issue to the applicant an Approval Document on Drug Clinical Trials.

After finishing the clinical trials, the applicant shall submit the clinical trial materials to the SFDA.

Article 96 If the SFDA considers that an application conforms to the relevant provisions, it shall issue to the applicant an Approval Document on Drug Registration as well as the Registered Number of Drug Approval. If it considers that the application doesn’t meet the relevant requirements, it shall issue to the applicant a Notification about the Examination Opinions and shall make an explanation.

As for a newly initiated drug manufacturing enterprises or a drug manufacturing enterprise that has newly established drug-manufacturing workshops or has newly added any form of drug preparation, if it fails to obtain a certificate of Criterions for the Quality Control of Drug Manufacturing specifying the corresponding certification scope, such drug manufactured by it shall not be marketed.

Article 97 The SFDA and the (food) drug administration of the province, autonomous region or municipality directly under the Central Government do not accept any application filed on the basis of tentative standards for the registration of drugs with existing state standards.

Article 98 With regard to an application for the registration of a drug with existing state standards that need further evaluation of the curative effect and safety, the SFDA may decide to suspend the acceptance or examination & approval of the application.

Article 99 If the 3 batches of drugs manufactured for the application for the registered number of drug approval were manufactured in workshops with a License for Drug Manufacturing and a certificate of Criterions for the Quality Control of Drug Manufacturing, those drugs may be marketed within their effective periods after passing the inspection conducted by the institute for drug control as prescribed in Articles 147 and 148 of the present Measures and obtaining the registered number of drug approval.

Chapter VII. Application and Examination & Approval of Imported Drugs

Section 1. Registration of Imported Drugs

Article 100 As to an application for the import of a drug, a permit for marketing as issued by the country or region where the overseas drug manufacturer is located must have been obtained; if no permit for marketing has been obtained, but the SFDA confirms that the said drugs are safe, effective and needed for clinical use, the import thereof may be approved.
The drug applied for import shall meet the criterions on quality control of drug manufacturing of the country or region where it is manufactured and the requirements of the Criterions for the Quality Control of Drug Manufacturing of China.

Article 101 To apply for the registration of imported drugs, an applicant shall file with the SFDA by filling in an Application Form for Drug Registration, submitting the relevant materials and samples and supply the relevant certification documents.

Article 102 The SFDA shall conduct a formal examination over the application materials, accept the application if the requirements are met, issue to the applicant an acceptance notice and give the National Institute for the Control of Pharmaceutical and Biological Products a notice of drug registration inspection. If it considers that the application doesn’t meet the relevant requirements, it shall reject it and give the applicant a notice about rejection of a drug registration application and shall make an explanation.

The SFDA shall, where it so requires, make on-spot investigations over the drug development process and manufacturing conditions.

Article 103 After finishing the registration inspection of the imported drug, the National Institute for the Control of Pharmaceutical and Biological Products shall submit the verified drug standards, inspection report and verification opinions to the SFDA.

Article 104 The SFDA shall organize a comprehensive evaluation of the application materials. It may demand the applicant to make supplements where necessary. If it believes that it is necessary to conduct clinical trials, it shall issue to the applicant an Approval Document on the Drug Clinical Trials. If it considers that the application doesn’t meet the relevant requirements, it shall issue to the applicant a Notification about the Examination Opinions and make an explanation.

Article 105 After the clinical trial has been approved, the applicant shall carry it out pursuant to Chapter IV of these Measures and the relevant requirements.
After the clinical trial is ended, the applicant shall fill out an Application for Drug Registration, submit the clinical trial materials, samples and other modified and supplemented materials pursuant to the provisions, offer the basis and reasons in details and supply the relevant certification documents.

Article 106 The SFDA shall make a comprehensive evaluation of the clinical trial materials submitted by an applicant and it may demand the applicant to make supplements where necessary. If it considers the applicant meets the relevant requirements, it may issue to it an Imported Drug Registration Certificate. Where a pharmaceutical manufacturer from Hong Kong, Macao or Taiwan applies for the registration of a drug, the procedures for applying for the registration of imported drugs shall apply; if it meets the relevant requirements, the SFDA shall issue to it a Pharmaceutical Product Registration Certificate; it if doesn’t satisfy the relevant requirements, the SFDA shall issue to it a Notification about Examination Opinions and make an explanation.

Article 107 As to an application for importing drug preparations, the applicant shall provide certifications of the legal sources of the packaging materials and containers have direct contact with the drugs, and certifications documents about the legal sources of the raw material medicines and supplementary materials used for manufacturing those preparations. If the raw material medicines and supplementary materials haven’t been approved by the SFDA, the applicant shall submit the study materials relating to the manufacturing techniques, quality indications and inspection methods.

Article 108 When approving the import of a drug, the SFDA shall simultaneously announce the ratified registration standards and specifications of the imported drug.

Section 2. Registration of Sub-packaging of Imported Drugs

Article 109 The Sub packaging of imported drugs shall refer to changing big drug packages into smaller ones after the final preparations are finished overseas, or making external packaging, placing specifications and affixing labels, etc. to the drugs of which the internal packaging has been finished.

Article 110 The following conditions shall be satisfied when an application is filed for sub packaging an imported drug:
(1) The applicant has already obtained a Imported Drug Registration Certificate or the Pharmaceutical Product Registration Certificate for the drug it applies for sub-packaging;
(2) The drug shall fall within a category that has not yet been manufactured within China, or within a category of which the manufacturing within China can’t meet the clinical needs;
(3)The same category of drug manufactured by the same drug manufacturer shall be sub-packaged by one drug manufacturing enterprise, and the sub-packaging period shall not exceed the effective period as specified in the Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate;
(4)Except for tablets and capsules, the sub-packaging of other types of preparations shall be completed abroad;
(5)The drug manufacturing enterprise that accepts the sub-packaging work shall hold a License for Drug Manufacturing. As to an application for sub-packaging any imported bare tablets or capsules within China, the drug manufacturing enterprise that accepts the sub-packaging work shall not only hold License for Drug Manufacturing, but also a certificate of the Criterions for the Quality Control of Drug Manufacturing in line with the form of drug to be sub-packaged; and
(6)An application for sub-packaging an imported drug shall be filed no later than 1 year prior to the expiration of the valid period of the Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate.

Article 111 An overseas drug manufacturer shall sign a contract on sub-packaging of imported drugs with the domestic drug manufacturing enterprise, and fill in a Drug Supplementary Application Form.

Article 112 To apply for the sub packaging of a imported drug, the applicant shall file with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise that accepts the sub-packaging work is located, submit a Drug Supplementary Application Form filled out by the entrusting party, as well as other relevant materials and samples. After the (food) drug administration of the province, autonomous region or municipality directly under the Central Government has conducted a formal examination over the application materials, and if it considers that the application meets the relevant conditions, it shall accept it and issue to the applicant a notice about the acceptance of the drug registration application. If it considers that the application doesn’t meet the relevant requirements, it shall reject it and shall give the applicant a rejection notice with the reasons of rejection.

After the (food) drug administration of the province, autonomous region or municipality directly under the Central Government puts forward its examination opinions, it shall submit the application materials and the examination opinions to the SFDA and shall simultaneously inform the applicant.

Article 113 The SFDA shall examine the application materials. If it considers that the application meets the relevant provisions, it shall approve it and issue to the applicant an Approval Document about the Drug Supplementary Application and a registered number of drug approval. If it considers that the application doesn’t satisfy the relevant conditions, it shall give the applicant a Notice about the Examination Opinions with the reasons of rejection.

Article 114 A sub-packaged imported drug shall comply with the registration standards for the imported drug.

Article 115 The specifications and packing labels of a sub-packaged imported drug shall be identical with those of the imported drug, and shall simultaneously be given a clear indication of the registered number of the approval of the sub-packaged drug as well as the name of the sub-packaging drug manufacturing enterprise.

Article 116 The import inspection of overseas preparations in large packages shall follow the relevant provisions of the SFDA. The same drug standards shall be observed in the inspection of sub-packaged products and the import inspection.

Article 117 The overseas pharmaceutical manufacturer that supplies a drug shall be responsible for the quality of the sub-packaged drug. If the sub-packaged drug has any quality problem, the SFDA may revoke the registered number of the approval of the sub-packaged drug. Where necessary, it may, in accordance with Article 42 of the Drug Administration Law, revoke the Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate pertaining to the drug.

Chapter VIII. Application and Examination & Approval of Nonprescription Drugs

Article 118 The term “nonprescription drugs” refers to the drugs promulgated by the SFDA that the customers may judge, purchase and use by themselves without the prescriptions given by practicing physicians and practicing assistant physicians.

Article 119 If a drug applied for registration is under any of the following circumstances, the applicant may simultaneously file an application for managing it as a nonprescription drug:
(1) It has already been manufactured or imported as nonprescription drug under the existing state drug standard;
(2) It is a drug of a changed form of a nonprescription drug as determined by the SFDA, but with the same applicable diseases, dosage administration and route of administration;
(3) It is a new compound preparation composed of the active ingredients of nonprescription drug determined by the SFDA.

Article 120 For a drug that meets the requirements in Article 119 (1) of the present Measures, the applicant shall, in the column “Supplementary Matters of Application” of the Drug Registration Application, indicate the item of nonprescription drug, the SFDA shall determine the drug as a nonprescription drug when approving the manufacturing or import of that drug. If the applicant fails to indicate the item of nonprescription drug in the Drug Registration Application, it shall, after the SFDA approves the drug registration, go through the register formalities in accordance with the relevant provisions on the management of classification between prescription drugs and nonprescription drugs, as well as the examination, approval and register of nonprescription drugs.

Article 121 For a drug that meets the relevant conditions as prescribed in Article 119 (2) or (3), the applicant may mark it as a nonprescription drug in the column “Supplementary Matters of Application” of the Drug Registration Application, and if the SFDA believes that it meets the relevant provisions regarding nonprescription drugs, it may, when granting approval for drug registration, determine it as a nonprescription drug. If it believes that it does not meet the relevant provisions regarding nonprescription drugs, it shall regard it as a prescription drug in its examination, approval and management process.

Article 122 As for a drug that meets the relevant conditions as prescribed in Article 119 of the present Measures, if the applicant fails to indicate the item of nonprescription drug in the column “Supplementary Matters of Application” of the Drug Registration Application, the SFDA shall regard it as a prescription drug in the examination, approval and management process.

Article 123 Generally speaking, no clinical trial is required for a chemical medicine as mentioned in Article 119 (1) or (2) of the present Measures, however, bioequivalence trials shall be conducted for a solid preparation for oral use. As for a finished Chinese traditional medicine, clinical trials shall be conducted for it pursuant to the relevant requirements of the present Measures.

Article 124 As for a drug as mentioned in Article 119 (3), the prescription basis shall be specified, and clinical trials shall be conducted for it where necessary.

Article 125 A non-prescription drug registration application, the specifications and packaging labels shall satisfy the relevant provisions on nonprescription drugs. The other application materials shall conform to the relevant provisions on prescription drugs.

Article 126 The procedures for the application, examination and approval of imported drug shall be applicable to an application filed for the registration of an imported drug as a nonprescription drug. The technical requirements for the said drug shall be in line with those for the domestically manufactured nonprescription drug.

Article 127 As to an application for the re-registration of an imported drug as a nonprescription drug, the SFDA shall complete the examination and approval formalities in accordance with the relevant provisions on the re-registration of imported drug as well as the management of nonprescription drugs. When applying for the re-registration of an imported drug as a nonprescription drug, the applicant isn’t required to go through the examination, approval and registration formalities for nonprescription drugs in the food and drug administration at the province level.

Article 128 As to a nonprescription drug upon approval of the SFDA, if it is found that it is improper to continue to manage it a nonprescription drug in the course of its use, the SFDA may modify it into a prescription drug.

Chapter IX. Drug Supplementary Application and Examination & Approval Thereof

Article 129 An applicant shall file a supplementary application when it modifies the drug approval certification document, its attached drug standards, drug specifications, any matter indicated in the labels, or the manufacturing techniques that may affect the drug quality.

Article 130 The applicant shall fill in a Drug Supplementary Application Form, and submit the relevant materials and explanations to the (food) drug administration of the province, autonomous region or municipality directly under the Central Government where it is located. The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall conduct a formal examination over the application materials. If it considers that the said application materials meet the relevant requirements, it shall accept them and shall give the applicant a notification about the acceptance of drug registration application. If it considers that the said don’t meet the relevant requirements, it shall reject them and give the applicant a notification about the rejection of drug registration application and shall make an explanation.

Article 131 For a supplementary application relating to an imported drug, the applicant shall submit the relevant materials and explanations to the SFDA, and present the modification approval document issued by the drug authorities of the country or region where the drug is manufactured. The SFDA shall conduct a formal examination over the application materials. If it considers that the said application materials meet the relevant requirements, it shall accept them and shall give the applicant a notification about the acceptance of drug registration application. If it considers that the said application doesn’t meet the relevant requirements, it shall reject the application and give the applicant a notification about the rejection of drug registration application and shall make an explanation

Article 132 As to a supplementary application for changing the enterprise name, drug packaging labels under the pertinent provisions, or the drug specifications pursuant to the requirements of the SFDA, the (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall, if it considers it meets the relevant requirement, accept and approve it upon examination, issue the applicant an Approval Document about the Drug Supplementary Application and submit the application to the SFDA for record. If it considers that the application doesn’t meet the relevant requirements, it shall give the applicant a Notification about the Examination Opinions and shall make an explanation.

Article 133 As to a supplementary application for modifying drug standards, altering supplementary materials, adding applicable diseases or functions of a drug, etc, after the (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall, after making examination and putting forward its examination opinions, submit it to the SFDA for examination and approval, and simultaneously notify the applicant.

Article 134 A supplementary application concerning an imported drug shall be subject to the examination and approval of the SFDA. A supplementary application for modifying the specifications, supplementing and perfecting the safety content in the specifications, changing the packaging label or appearance of the drug, or modifying the registration agency in accordance with the state drug standards, or requirements of the SFDA, shall be subject to recording by the SFDA. If the SFDA raises no objection within 0 days after the acceptance, the applicant may execute that supplementary application.

Article 135 As to a supplementary application for the change of the drug manufacturing place or for a registered number of drug approval upon the strength of a new drug certificate, the (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall check the trial manufacturing place, select samples for inspection use, and notify the designated institute for drug control to make an inspection over the samples.

As to a supplementary application for modifying the drug standards, the institute for drug control shall review the standard if necessary.

Article 136 When examining a drug supplementary application, the SFDA may demand the applicant to submit supplementary materials. If it considers that the drug supplementary application meets the relevant requirements, it shall grant to the applicant an Approval Document on Drug Supplementary Application. If it considers that the application doesn’t meet the relevant requirements, it shall give the applicant a Notification about its Examination Opinions and make an explanation.

If it is needed to replace the drug approval certification document by a new one, the original one shall be written off by the SFDA. If it is needed to issue any more drug approval certification document, the original one shall remain valid.

Article 137 The valid term of the approval certification document for a drug supplementary application shall be identical with that of the original drug approval certification document, and a new application for re-registration shall be filed when the said valid term expires.

Chapter X Re-registration of Drugs

Article 138 The “re-registration of a drug” shall refer to the examination and approval conducted on a drug which the manufacturer continues to manufacture or import after the valid term of the drug approval certification document expires.

Article 139 The valid term of the registered number of drug approval, Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate issued by the SFDA shall be 5 years. If the manufacturing or import needs to continue after the expiration of the valid term, the applicant shall apply for re-registration within 6 months prior to the expiration date.

Article 140 An application for the re-registration of a drug shall be filed by a drug manufacturing enterprise that has obtained a registered number of drug approval with the (food) drug administration of the province, autonomous region or municipality directly under the Central Government. The drug manufacturing enterprise shall fill in a Drug Re-registration Application Form and supply the relevant application materials.

An application for the re-registration of an imported drug shall be filed by an applicant with the SFDA.

Article 141 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall examine the application materials. If it considers that they meet the relevant requirements, it shall accept them and issue to the applicant a notification about the acceptance of the drug re-registration application. If it considers that they don’t meet the relevant requirements, it shall reject them, give the applicant a notification about rejecting the drug re-registration application and make an explanation.

Article 142 The (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall put forward its examination opinions on a drug re-registration application within 3 months and shall submit them to the SFDA for examination and approval.

If the SFDA fails to issue a notice of disapproval of re-registration within 3 months after it receives the examination opinions, the (food) drug administration of the province, autonomous region, or municipality directly under the Central Government shall re-register the drug.

Article 143 The SFDA shall finish the examination within 6 months after it accepts an application for the re-registration of an imported drug. If it considers the said application meets the relevant requirements, it shall re-register the drug to be imported.

Article 144 A drug, which is under any of the following circumstances, shall not be re-registered: (1) An application for re-registration fails to be filed within the prescribed period;
(2) The relevant requirements set forth by the SFDA for approval of marketing fails to be met;
(3) The applicant fails to finish the Phase IV clinical trials pursuant to the requirements;
(4) The applicant fails to monitor the drug adverse reactions pursuant to the provisions;
(5) The drug falls within a to-be-eliminated category upon re-evaluation of the SFDA;
(6) The drug approval certification document should be revoked pursuant to the Drug Administration Law;
(7) The manufacturing enterprise fails to meet the conditions for manufacturing as provided for in the Drug Administration Law;
(8) The applicant fails to perform its duties during the monitoring period;
(9) Other circumstances in violation of the relevant provisions.

Article 145 If an application doesn’t meet the relevant requirements for the re-registration of a drug, the SFDA shall issue a notice of disapproval of re-registration and shall make an explanation. Unless the drug approval certification document has been revoked due to any statutory reason, the SFDA shall write off the registered number of drug approval, Imported Drug Registration Certificate or Pharmaceutical Product Registration Certificate when the valid term expires.

Chapter XI. Management of Drug Registration Inspection

Article 146 The drug registration inspection shall be conducted at the application for drug registration. The drug registration inspection shall include sample inspection and drug standard review relating to the drug applied for registration.

The sample inspection shall refer to the inspection conducted by the institute for drug control on the samples pursuant to the drug standard supplied by the applicant.

The Drug standard review shall refer to the lab inspection and examination conducted by the institute for drug control for the purpose of determining the feasibility, scientificness of the inspection methods specified in the drug standard, and whether or not the items and indicators set can control the drug quality.

Article 147 The drug registration inspection shall be undertaken by an institute for drug control of the province, autonomous region or municipality directly under the Central Government. The registration inspection of imported drugs shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products.

Article 148 The registration inspection of the following drugs shall be undertaken by the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control designated by it:
(1)The drugs listed in Items (1) and (2) of Article 48 of the present Measures;
(2)The biological products and radioactive drugs;
(3) Other drugs as provided for by the SFDA.

Article 149 For a drug conforming to the provisions of Article 48 of these Measures, the institute for drug control shall give priority to it when arranging an inspection and drug standard review.

Article 150 An institute undertaking the drug registration inspection shall, pursuant to the requirements of the Criterions on the Administration of Quality Control of the Laboratories of Institutes for Drug Control and the requirements of national metrological authentication, be equipped with the personnel and facilities that match with the tasks of drug registration inspection, the quality guarantee system and technical requirements of drug registration inspection

Article 151 The applicant shall provide the institute for drug control with the relevant materials needed, submit the samples or assist it in selecting samples for inspection use, and provide the standard materials for inspection use. The quantity of the samples shall be 3 times of that used in the inspection, and the manufacturing check records of the corresponding batches shall also be offered for the registration inspection of a biological product.

Article 152 As to an application for manufacturing a drug with existing state standards, the institute for drug control shall, after the receipt of the samples, conduct an inspection pursuant to the state standards, and make a comprehensive analysis of the changes of quality indicators resulting from the change of techniques, and if necessary, it shall request the applicant to work out the corresponding quality indicators and inspection approaches so as to ensure the controllability of the drug quality.

Article 153 As to the review of the standards of a new drug, the institute for drug control shall, apart from making inspection over the samples, put forward its review opinions on the drug standard, inspection items and methods for the inspected drug pursuant to the study data of the drug, the standards for drugs of the same category at home and abroad and the relevant requirements of the state.

The institute shall inform the applicant, if necessary, before giving its review opinions. If the applicant has any objections, it shall present its complaint to the institute within 10 days. If the institute disagrees with the complaint of the applicant, it shall submit its review opinions and the applicant’s complaint to the SFDA together, and shall send a copy to the applicant as well as the drug administration of the province, autonomous region or municipality directly under the Central Government which notified it about drug registration inspection.

Article 154 Where an applicant is required to the reformulate the drug standards, it shall not entrust the institute for drug control that put forward the original review opinions to carry out the study of the drug; neither may that institute accept such an entrustment.

Chapter XII Administration of the Drug Registration Standards

Section 1. Basic Requirements

Article 155 The state drug standards shall refer to the technical requirements for quality indicators, inspection methods and manufacturing techniques etc. set forth by the state in order to ensure the drug quality, including the Drug Code of the People’s Republic of China, the drug registration standards and other drug standards promulgated by the SFDA.
The drug registration standards shall refer to the certain drug standards which the SFDA has granted an approval to the applicant for a certain drug and with which the corresponding drug manufacturing enterprise shall comply.

Article 156 The items of a drug registration standard and the setting of the inspection methods thereof shall conform to the technical guiding principles as well as the principles and detailed rules promulgated by the SFDA on working out the state drug standards.

Article 157 An applicant shall, on the precondition that the quality of the raw materials and the manufacturing techniques are stable, select some typical samples to conduct study for the standards.

Section 2. Formalization of Tentative Drug Standards

Article 158 After the manufacturing of a new drug has been approved, the drug standards thereof shall be tentative standards, and the tentative period shall be 2 years. For other drugs, if further investigation shall be carried out over the manufacturing techniques and the stability of the product quality after the manufacturing has been approved, the drug standards thereof may also be approved as tentative standards.

Article 159 A drug manufacturing enterprise permitted to manufacture a drug under tentative standards shall, 3 months prior to the expiration of the tentative period, file an application of formalization of the standards with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and shall fill out a Drug Supplementary Application Form, and submit the quality assessment materials of the drug within the tentative period of the standards, as well as the opinions on revising the tentative standards.

After a supplementary application for revising the drug registration standards is approved before the expiration of the tentative period of former drug standards, the applicant shall file a formalization application 3 months prior to the expiration of the tentative period of former drug standards.

Article 160 The (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall finish the examination within 10 days from the day when receives an application for the formalization of the tentative drug standards, and shall submit the examination opinions and the relevant materials to the SFDA.

Article 161 The SFDA shall organize the State Drug Code Committee to comprehensively examine and evaluate the tentative drug standards.

The State Drug Code Committee shall, as required by the implementation of the drug standards during the tentative period, the standards for the relevant products home and abroad or the relevant state requirements, put forward its opinions on whether or not the said drug standards need to be reviewed. If the standard needs to be reviewed, the relevant institutes for drug control shall be organized to carry out the review and inspection of the tentative drug standards.

Article 162 The inspection and review for the formalization of tentative standards on drugs in the same category manufactured by several drug manufacturing enterprises shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products or the institute for drug control designated by the SFDA.

Article 163 If different applicants apply for the formalization of the tentative standards of drugs in the same category, the standards approved later shall not be lower than those approved earlier, and necessary inspection items shall be added in light of their respective technique characteristics.

Article 164 After an applicant receives a notice about the review and inspection of standards, if it needs to conduct supplementary trials or perfect the materials, it shall complete them within 50 days and shall submit the relevant materials to the (food) drug administration of a province, autonomous region or municipality directly under the Central Government.

Article 165 The SFDA shall examine the materials submitted by the State Drug Code Committee. If it considers that these materials meet the relevant requirements, it shall issue to the applicant a Promulgation Document of State Drug Standards and approve the formalization of the tentative drug standards. If it considers that these materials don’t meet the relevant requirements, it shall give the applicant a Notification about its Examination Opinions and make an explanation, and simultaneously revoke these tentative drug standards as well as the registered number of approval for the drug manufactured under the tentative standards.

Article 166 With respect to drugs of a same category whose tentative standard period expires on different dates, the formalization of those that expires earlier shall be handled earlier. And for the drugs whose tentative standard period hasn’t expired, the State Drug Code Committee shall notify the applicants to file an application for formalization in advance with the (food) drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government.

Article 167 If the applicant fails to file an application for formalization at the expiration of the tentative standard period, the SFDA shall revoke these tentative standard concerned and the registered number of approval for the drugs manufactured under such tentative standard.

During the period when an application for formalization of a tentative standard is handled, the drug manufacturing enterprise shall manufacture drugs pursuant to the tentative standard concerned.

Section 3. Administration of Drug Standard Substances

Article 168 The term “drug standard substances” refers to the substances including standard articles, comparison articles, comparison medicine materials and reference articles that are used in the physical and chemical testing as well as in the trials through biological methods as specified in the drug standards, have determinable quantitative values and are used for calibrating the equipment, assessing the measurement methods or evaluating the value of the drug for experiment.

Article 169 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for defining the state drug standard substances.
The National Institute for the Control of Pharmaceutical and Biological Products may organize the institutes for drug control, institutions for drug study or drug manufacturing enterprises of the relevant provinces, autonomous regions and municipalities directly under the Central Government to define the state drug standard substances collaboratively.

Article 170 When applying for manufacturing a new drug, the applicant shall submit the raw materials for preparing such drug standard substances and the relevant research standard materials about the standard substances to the National Institute for the Control of Pharmaceutical and Biological Products

Article 171 For the defined standard substances, the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for conducting a comprehensive technical examination of such materials as the selection of raw materials, the preparing methods, the defining methods, the defining results, the accuracy of fixed values, the measurement traceability, the stability, and the conditions for sub-packaging and packaging, etc., and shall make a conclusion about whether or not these substances may be used as state drug standard substances.

Chapter XIII. Time Limit for and General Provisions on Drug Registration

Article 172 The SFDA and the (food) drug administrations of the provinces, autonomous regions, municipalities directly under the Central Government shall each publish the conditions, procedures, time limit and the list of complete set of materials for drug registration as well as the models texts of the application forms on the website of the administrative organs as well as in the drug registration sites.

Article 173 When the SFDA or the (food) drug administration of a province, autonomous region or municipality directly under the Central Government accepts or rejects a drug registration application, it shall issue to the applicant a written document which shall bear the seal for the exclusive use of acceptance of drug registration and shall give a clear indication of the date.

Article 174 The Time limit for drug registration shall refer to the maximum time period, during which the examination, inspection and supplementing of materials relating to drug registration shall be completed. The tasks that have been completed within the time limit for drug registration shall be timely shifted to the next procedure.

Article 175 After the (food) drug administration of a province, autonomous region or municipality directly under the Central Government receives an application, if the application materials are incomplete or don’t satisfy the requirements for formal examination, it shall, within 5 days, inform the applicant, all at once, of the contents to be corrected or supplemented. If fails to do so within the time limit, it shall be deemed that the administration has accepted the application on the day when it receives the application materials.

If the application materials are complete and meet the requirements for formal examination, or if the applicant has submitted all the supplementary materials as required, it shall accept the application within 5 days.

Article 176 The (food) drug administration of a province, autonomous region or municipality directly under the Central Government shall begin to organize relevant work within 5 days after it accepts an application and shall, within 30 days, complete the tasks such as conducting on-the-spot inspection, selecting samples, giving the institute for drug control a registration inspection notice, submitting an examination report, inspection report as well as the applicant’s application materials to the SFDA, and shall simultaneously notify the applicant of its examination opinions.

Article 177 After the institute for drug control receives a registration inspection notice and the samples, it shall complete the inspection within 30 days and shall issue a drug registration inspection report.

For a special drug and vaccine product, the inspection may be finished within 60 days.

Under Article 32, the inspection of samples for clinical trial use, which must be conducted in a designated institute for drug control, shall be completed pursuant to provisions in the preceding two paragraphs regarding the time limit.

Article 178 If the inspection over samples and review of drug standard are needed, an institute for drug control shall finish the inspection and the review within 60 days.

For special drugs and vaccine products, the inspection and review may be finished within 90 days.

Article 179 As to an application for the registration of an imported drug, the SFDA shall conduct a formal examination. If it considers that it meets the relevant requirements, it shall accept it within 5 days. If it considers that it doesn’t meet the relevant requirements, it shall, within 5 days, give a written notice to the applicant and make an explanation. If it fails to do so, it shall be deemed to have accepted the application materials on the day when it receives them.

Where the SFDA informs the National Institute for the Control of Pharmaceutical and Biological Products of a task, such as conducting registration inspection or determining the matters relevant to the examination and approval or evaluation, the National Institute for the Control of Pharmaceutical and Biological Products shall complete it within 30 days after it accepts it.

Article 180 After the National Institute for the Control of Pharmaceutical and Biological Products receives the materials and samples, it shall, within 5 days, arrange a relevant institute for drug control to conduct a registration inspection.

Article 181 An institute for drug control undertaking the registration inspection over imported drugs shall, after receiving the materials, samples and relevant standard substances, finish the registration inspection within 60 days and send an drug registration inspection report to the National Institute for the Control of Pharmaceutical and Biological Products.

As to an inspection over the samples of a special drug or vaccine product or for verifying the standards on a drug, it shall be completed within 90 days.

Article 182 After the National Institute for the Control of Pharmaceutical and Biological Products receives a drug registration inspection report or verified standards on an imported drug, it shall, within 20 days, organize experts to conduct a technical examination, and if necessary, it may conduct a re-check according to their examination opinions.

Article 183 When handling an application for the registration of a drug, the SFDA shall observe the following provisions concerning the time limit for technical evaluation:
(1) For clinical trials of a new drug: within 120 days; for a drug conforming to the provisions of Article 48 of these Measures: within 100 days.
(2) For manufacturing a new drug: within 120 days; for a drug conforming to the provisions of Article 48 of these Measures: within 100 days.
(3) For an application for a drug with existing state standards: within 80 days;
(4) For supplementary application that is subject to technical evaluation: 40 days.

This Article shall also be observed with respect to the time limit for the technical evaluation in handling an application for the registration of an imported drug.

Article 184 When the SFDA conducts a technical evaluation over a drug registration application, if it needs the applicant to offer supplementary materials, it shall, once and for all, give it a notice about the materials to be supplemented.

Except for an application as mentioned in Article 48 of the present Measures, the applicant shall, within 4 months, submit, once and for all, the supplementary materials as required in the notice. If it fails to do so within the time limit, the SFDA shall reject its application.

Article 185 If the applicant objects to the notice about the materials to be supplemented, it shall raise its objections within the prescribed time limit. If it still has any objections, it may directly submit its written objections as well as the reasons, technical materials and scientific basis to the SFDA. for examination and decision.

Article 186 Where an application is withdrawn by the applicant on its own initiative or is rejected, and if the applicant needs to file a new application, it may go through the original application procedures after it has supplemented the trial or perfected the relevant materials.

If an application meets the relevant requirements and if no identical drug enters into the new drug monitoring period, the SFDA and the (food) drug administration of the province, autonomous region or municipality directly under the Central Government shall accept this application.

Article 187 The SFDA shall, after receiving the supplementary materials, finish the technical evaluation within a period which does exceed more than one third of the originally prescribed time period. If an application conforms to the provisions of Article 48 of these Measures, the technical evaluation shall be completed within a period which does not exceed more than one fourth of the originally prescribed time period.

Article 188 The SFDA shall finish the examination and approval within 20 days after finishing the technical evaluation. For a drug supplementary application that shall be subject to the approval of the SFDA, the SFDA shall complete the examination and approval within 20 days.

If the SFDA can’t complete the examination and approval within 20 days, it may extend the time limit by 10 days upon approval of the corresponding leader of the SFDA. An extension exceeding 10 days shall be subject to the approval of the State Council.

Article 189 The State Drug Code Committee shall finish the examination and decision on the formalization of a tentative drug standard within 60 days.

An institute undertaking the task of standard review and inspection shall finish the review and inspection within 60 days, and send its review opinions and inspection report to the State Drug Code Committee. For special drugs and vaccine products, the period shall not exceed 90 days as a general rule. And the review and inspection for the formalization of the tentative standards for the drugs of a same category manufactured by several drug-manufacturing enterprises shall be finished within 80 days.

Article 190 When SFDA or the (food) drug administration of the provinces, autonomous region or municipality directly under the Central Government examines a drug registration application, it shall announce the examination and approval procedures and results. The applicant and the interested parties may submit their written opinions about the matters of great significance to their interests so as to make statements and arguments.

Article 191 When the SFDA or the (food) drug administration of the provinces, autonomous region or municipality directly under the Central Government makes a written decision of rejection or disapproval, it shall make an explanation and shall inform the applicant of the right to apply for administrative reconsideration or lodge an administrative lawsuit.

Article 192 The SFDA or the (food) drug administration of the provinces, autonomous region or municipality directly under the Central Government shall inform the applicant of the right to apply for a hearing. If the food and drug administration considers that any public interests are involved in the process of drug registration, it shall make an announcement to the general public and hold a hearing.

Article 193 After the SFDA makes a decision of drug registration examination and approval, it shall issue and serve the decision upon the applicant within 10 days.

Article 194 The SFDA shall, on its government website, regularly publish the list of drugs that have passed examination and approval for the consultation of the general public.

Article 195 If it is necessary to extend the time limit for the drug registration inspection or technical evaluation due to any special circumstance, the extension shall be subject to the approval of the SFDA.

Article 196 Under any of the circumstances as prescribed in Article 70 of the Administrative License Law of the People’s Republic of China (hereinafter referred to the Administrative License Law), the SFDA shall complete the formalities for writing off the relevant drug approval certification documents.

Article XIV. Re-examination

Article 197 If an applicant has any objection against the decision made by the SFDA, before it applies for an administration reconsideration or lodge an administrative lawsuit, it may fill out Drug Supplementary Application Form within 10 days, file with the SFDA for re-examination and present the reasons for re-examination.

The matters of re-examination shall be limited to those included in the original application.

Article 198 After the SFDA receives a re-examination application, it shall make a re-examination decision within 50 days and shall notify the applicant of the decision. If it maintains the original decision, it shall not accept the re-examination application filed by the applicant for a second time.

Article 199 If it is necessary to conduct technical evaluation in the re-examination, the SFDA shall organize the relevant professional technicians to do so by following the time limit for the original application.

Chapter XV. Legal Liabilities

Article 200 Under any of the circumstances as prescribed in Article 69 of the Administrative License Law, the SFDA may revoke the relevant drug approval certification documents at the request of any interested party or according to its own power.

Article 201 When applying for clinical trials, if the applicant submits any false drug registration application materials or samples, the SFDA shall reject the application materials or disapprove the application for clinical trials of the drug, give the applicant a warning, and shall not accept any new application filed by this applicant for clinical trials of this drug within 1 year. If the SFDA has granted approval for clinical trials, it shall revoke the official documents about the clinical trials of this drug and impose a monetary penalty in the sum of 10,000 yuan up to 30,000 yuan upon the applicant and shall not accept any new application filed by it for clinical trials of this drug within 3 years.

The SFDA shall establish bad conduct records of the applicants submitting false materials and samples and announce them to the general public.

Article 202 When applying for manufacturing or importing a drug, if the applicant submits any false drug registration application materials or samples, the SFDA shall reject or disapprove this application, give the applicant a warning, and shall not accept any new application filed by this applicant within 1 year. If the SFDA has granted to it approval for manufacturing or importing the drug, it shall revoke the official documents, shall not accept any new application filed by it within 5 years and impose a monetary penalty in the sum of 10,000 yuan up to 30,000 yuan upon the applicant.

The SFDA shall establish bad conduct records of the applicants submitting false materials and samples and announce them to the general public.

Article 203 If the SFDA, or the (food) drug administrations of a province, autonomous region or municipality directly under the Central Government, or any of its staff member violates the present Measures during the drug registration process, and if it (he) is under any of the following circumstances, it (he) shall be punished in accordance with Articles 72 through 75 of the Administrative License Law:
(1) Rejecting any drug registration application that meets the statutory conditions;
(2) Failing to publish the application materials as required for drug registration in the acceptance place;
(3)Failing to perform the statutory obligation of making the applicant informed during the course of acceptance, examination and approval;
(4)Failing to inform, once and for all, the applicant of the items to be supplemented and corrected where the drug application materials submitted by an applicant are incomplete or don’t conform to the statutory form;
(5)Failing to make an explanation about the rejection or disapproval of the drug registration application;
(6)Making a decision to approve a registration application that doesn’t meet the prescribed conditions, or making a decision of approval by exceeding the statutory power;
(7)Making a decision to disapprove a registration application that meets the prescribed conditions, or failing to make a decision of approval within the time limit as specified in the present Measures;
(8)Charging fees illicitly or failing to charge fees according to the standards on the statutory items; or
(9)Extorting or accepting any property of others or seeking other benefits.

Article 204 If the License for Drug Manufacturing of a drug manufacturing enterprise is revoked, the registered number of approval of the drug of this enterprise shall be invalidated automatically, and the SFDA shall write off the said registered number of approval and make an announcement to that end.

Article 205 Any enterprise that fails to comply with the Criterions for the Quality Control of Non-clinical Study of Drugs or the Criterions for the Quality Control of Clinical Trials of Drugs, it shall be punished in accordance with Article 79 of the Drug Administration Law.

Article 206 Where an institution for drug control issues a false inspection report when undertaking the inspection for drug examination and approval, it shall be punished pursuant to Article 97 of the Drug Administration Law.

Article 207 If, under Article 21 of the present Measures, the applicant refuses to conduct repetitive drug trials as required, the SFDA shall give it a warning and order it to make corrections. If the applicant refuses to make corrections, the SFDA shall disqualify it from applying for the registration of the drug.

Chapter XVI Supplementary Provisions

Article 208 The format of the registered number of approval of a drug: Guoyaozhunzi H (Z, S, J) + 4-digit year number + 4-digit sequential number, of which H stands for chemical drugs, Z for Traditional Chinese Medicines, S for biological products and J for sub-packaged imported drugs.

The format of the number of an Imported Drug Registration Certificate: H (Z, S) + 4-digit year number + 4-digit sequential number, of which H stands for chemical drugs, Z for Traditional Chinese Medicines, S for biological products. If a drug sub-packaged within China uses the registration certificate of the outer packages, its number shall be prefixed by “B”.

The format of the number of a new drug registration certificate: Guoyaozhengzi H (Z, S) + 4-digit year number + 4-digit sequential number, of which H stands for chemical drugs, Z for Traditional Chinese Medicines, S for biological products.

Article 209 An application for the registration of narcotics, psychotropic drug, toxic drug for medical use or radioactive drug shall not only go through the formalities as mentioned in the present Provisions, but also conform to the other provisions of the state.

Article 210 The provisions on the administration of the registration of traditional Chinese medicinal materials, herbal medicines for decoction or imported traditional Chinese medicinal materials, which are subject to the registered number of approval, shall be formulated by the SFDA separately.

The administrative measures for the registration of external diagnostic reagents shall be separately formulated by the SFDA.

Article 211 The present Measures shall be implemented as of May 1, 2005. The Administrative Measures for the Registration of Drugs (for Trial Implementation) promulgated by the SFDA on October 30, 2002 shall be simultaneously abolished.

Annex 1. The Registration Classification of Traditional Chinese Medicines and Natural Medicines, and Requirements for Application Materials (Omitted)

Annex 2. The Registration Classification of Chemical Drugs and Requirements for Application Materials (Omitted)

Annex 3. The Registration Classification of Biological Products and Requirements for Application Materials (Omitted)

Annex 4. The Items for Drug Supplementary Registration Application and Requirements for Application Materials (Omitted)

Annex 5. The Item of Drug Re-registration Application Materials (Omitted)