(Approved at the 7th meeting of the Standing Committee of the 5th National People's Congress on September 20, 1984 and amended at the 20th meeting of the Standing Committee of the 9th National People's Congress on February 28, 2001.)
Table of Contents
Chapter 1 General Principles
Chapter 2 Administration of Drug Manufacturing Enterprises
Chapter 3 Administration of Drug Operation Enterprises
Chapter 4 Administration of Medications of Medical Institutions
Chapter 5 Administration of Drugs
Chapter 6 Administration of Drug Packaging
Chapter 7 Administration of Drug Prices and Advertising
Chapter 8 Supervision of Drugs
Chapter 9 Legal Responsibilities
Chapter 10 Miscellaneous
Chapter 1: General Principles
Article 1: This Drug Administration Law of the People's Republic of China [hereinafter "Law"] is promulgated in order to strengthen administration of drugs, ensure the quality and safe and efficacious use of drugs, and protect the health and the legitimate rights and interests of people in using drugs.
Article 2: The Law shall be observed by all units or individuals engaged in drug research, manufacturing, operation, use or administration of drugs within the territory of the People's Republic of China.
Article 3: The national government shall develop both modern drugs and traditional Chinese medicines and give them full play in disease prevention, medical treatment and healthcare.
The national government shall protect wild medicinal resources and encourage the cultivation of Chinese medicinal materials.
Article 4: The national government shall encourage the research and development of new drugs, and protect the legitimate rights and interests of citizens, legal persons and other organizations in researching and developing new drugs.
Article 5: The drug administration department of the State Council (hereinafter interpreted as "SDA") shall be in charge of national drug administration affairs. Other relevant departments of the State Council shall be responsible for the drug administration affairs within their authority.
The drug administration department of the people's government of each province, autonomous region, or municipal city is responsible for the drug administration affairs within its authority. Other relevant departments of the people's government of each province, autonomous region, or municipal city are also responsible for the relevant drug administration affairs within their respective authority.
SDA shall cooperate with other departments under the State Council responsible for overall economic affairs to implement national development plans and policies for the pharmaceutical industry.
Article 6: Drug administration department shall establish or designate drug inspection organizations to undertake drug inspection work requested for drug evaluation and approval and drug quality control according to relevant regulations and laws.
Chapter 2: Administration of Drug Manufacturing Enterprises
Article 7: To establish a drug manufacturing enterprise, a drug manufacturer shall obtain the approval from and the License for Drug Manufacturing Enterprise issued by the drug administration department of the people's government of the province, autonomous region or municipal city where the manufacturing enterprise is located. The drug manufacturer shall register with the administration department for industry and commerce on the basis of the License for Drug Manufacturing Enterprise. Engaging in drug manufacturing activities without the License for Drug Manufacturing Enterprise is prohibited.
The validity period and the business scope shall be clearly noted on a License for Drug Manufacturing Enterprise, which shall be reviewed and renewed upon expiration.
To approve the establishment of a pharmaceutical manufacturing enterprise, the drug administration department shall not only comply with the requirements specified in the Article 8 of this Law, but also comply with relevant national development plans and policies for the pharmaceutical industry so as to avoid redundant construction.
Article 8: To establish a drug manufacturing enterprise, the following requirements shall be met:
(a) The enterprise shall have pharmacological personnel, engineering personnel and other corresponding technicians whose qualifications have been certified according to relevant regulations.
(b) The enterprise shall be equipped with factory buildings, facilities and hygienic environment appropriate for the pharmaceutical production.
(c) The enterprise shall have departments, personnel and necessary equipment for quality management and control of the drugs it manufactures.
(d) The enterprise shall have adopted relevant regulations and rules to ensure the quality of the drug it manufactures.
Article 9: A drug manufacturing enterprise shall observe the Good Manufacturing Practices for Pharmaceutical Products [GMP], promulgated to according to this Law by SDA. The drug administration department shall conduct certification on drug manufacturing enterprises according to the requirements of GMP, and issue a GMP certificate to a qualified drug manufacturing enterprise.
SDA shall be responsible for the promulgation of the working rules and implementation procedures of GMP.
Article 10: Except for the preparation of TCM, a drug shall be produced in compliance with national drug standards and the manufacturing process approved by SDA. Production records shall be complete and accurate. For any change, a drug manufacturer shall apply for approval of a production process that may affect drug quality from the drug administration department which originally approved the manufacturing process.
TCM shall be prepared in compliance with national drug standards, or in the absence of national standards, with relevant standards established by local drug administration departments of the province, autonomous region or municipal city. The standards for TCM preparations set by the local drug administration department of the people's government of province, autonomous region or municipal city shall be submitted for approval to SDA.
Article 11: Raw materials and excipiants used for drug manufacturing shall meet relevant requirements for pharmaceutical use.
Article 12: A drug manufacturing enterprise shall conduct quality inspection on the products it manufactures. A drug that fails to conform with relevant national drug standards, or TCM preparation standards established by local drug administration departments of the people's government of relevant province, autonomous region or municipal city, shall not be allowed to leave the factory.
Article 13: A drug manufacturing enterprise may undertake toll manufacturing upon the approval of SDA, or with the approval of local drug administration department of the people's governments of provinces, autonomous regions and municipal cities authorized by SDA.
Chapter 3: Administration of Drug Operation Enterprises [Wholesalers and Retailers]
Article 14: A drug wholesale enterprise shall obtain approval for business operation and a License for Drug Operation Enterprise from the local drug administration department of the people's government at the level of province, autonomous region or municipal city. A drug retail enterprise shall obtain approval for business operation and a License of Drug Operation Enterprise from the local drug administration department of the people's government above county level. The registration with the relevant industry and commerce administration department shall be on the basis of the License of Drug Operation Enterprise. Engaging in a drug operation business without a License of Drug Operation Enterprise is prohibited.
The validity period and the business scope shall be clearly noted on a License for Drug Operation Enterprise, which shall be reviewed and renewed upon expiration. In approving the establishment of drug operation enterprise, drug administration department shall not only comply with the requirements specified in Article 15 of this Law but also observe the principles of reasonable layout [of drug operation enterprises] and convenient access [to drugs] by people.
Article 15: To establish a drug operation enterprise, the following requirements shall be met:
(a) The enterprise shall have pharmacological personnel whose qualifications has been certified according to relevant law.
(b) The enterprise shall have a business site, equipment, storage facilities and hygienic environment appropriate for its drug operation business.
(c) The enterprise shall have quality management departments and personnel commensurate with its drug operation business.
(d) The enterprise shall have adopted relevant regulations and rules to ensure the quality of drugs in its operations.
Article 16: A drug operation enterprise shall observe the Good Sales Practices for Pharmaceutical Products [GSP], which is formulated according to this Law by SDA. The drug administration departments shall certify drug operation enterprises according to the requirements of GSP, and issue GSP certificates to qualified drug manufacturing enterprises.
SDA shall be responsible for the promulgation of the working rules and implementation procedures of GSP.
Article 17: A drug operation enterprise shall establish and implement a check and acceptance system to verify the quality certificates and other labels of drugs before purchase. Drugs that fail to meet relevant requirements shall not be purchased.
Article 18: A drug operation enterprise shall keep true and complete records of the purchase and sale of drugs. The records shall clearly indicate the generic names, dosage forms, specifications, batch numbers, validity periods, manufacturing factory, procurement (selling) units, procurement (selling) quantity, procurement (selling) prices, procurement (selling) dates and other items required by SDA.
Article 19: A drug operation enterprise shall sell drugs in an accurate way, correctly indicating methods and quantity of administration and precautions. A prescription shall be checked before filling. A drug listed on a prescription shall not be arbitrarily changed or substituted. If a prescription contains drugs not compatible or with too high a dosage, the prescription shall not be filled and the drug not sold. If necessary, only after the original prescribing physician corrects or re-signs the prescription, may the drug be prepared and sold.
TCM shall be clearly marked with the place of origin.
Article 20 A drug operation enterprise shall establish and implement rules for drug storage, and adopt necessary measures such as refrigeration, and methods which prevent freezing, humidity, insects, mice, etc. to ensure drug quality. Before being admitted to and delivered from a warehouse, a drug shall be checked according to relevant rules.
Article 21 TCM (herbs) may be traded at country fairs in urban and rural areas, except for those separately regulated by the State Council.
Drugs other than TCM shall not be sold at country fairs in urban and rural area. However, a drug retail enterprise with a License of Drug Operation Enterprise may set up sales branches at country fair in urban and rural area to sell drugs other than TCM herbs according to its approved business scope. The State Council shall be responsible for the promulgation of relevant implementation methods.
Chapter 4: Administration of Drugs and Preparations in Medical Institutions
Article 22: A medical institution shall have pharmacological professionals whose qualifications have been certified according to relevant laws. Non-pharmacological professionals shall not directly engage in relevant technical work of drugs and preparations.
Article 23: To make preparations, a medical institution shall obtain approval from the health administration department of the region where the medical institution is located, and obtain a License for Medical Institution to Make Preparations issued by the drug administration department of the people's government at the province, autonomous region or municipal city where the medical institution is located. Making preparations without a License for Medical Institution to Make Preparations is prohibited.
The validity period must be clearly indicated on the License for Medical Institution to Make Preparations. The License for Medical Institution to Make Preparations shall be reviewed and renewed upon expiration.
Article 24: To make preparations, a medical institution shall be equipped with necessary facilities, administration regulations, testing instruments and hygiene environment to ensure the quality of preparations.
Article 25: The preparation prepared by a medical institution shall be of the kind not available in the market, but clinically needed by the medical institution. The preparation shall not be prepared until it is approved by the drug administration department of the people's government of the province, autonomous region or municipal city where the medical institution is located. The preparation shall pass quality inspection according to relevant regulations and shall only be used within the institution according to a doctor's prescription. Under special circumstances, a preparation prepared by a medical institution may be used by other designated medical institutions with the approval of SDA or of the people's government at the level of province, autonomous region or municipal city.
Preparations prepared by medical institutions are prohibited from being sold in the market.
Article 26: A medical institution shall establish and implement a check and acceptance system to check quality certificate documents and other labels of the drugs before purchasing. It is forbidden to purchase or prescribe the drugs that are not in compliance with relevant requirements.
Article 27: Pharmacists in a medical institution shall check a prescription before filling it. Drugs listed on the prescription shall not be arbitrarily changed or substituted. If a prescription contains drugs not compatible or with too high a dosage, the prescription shall not be filled and the drug not sold. If the drug is necessary, only after the original prescribing physician corrects or re-signs the prescription, may the drug be prepared and sold.
Article 28: A medical institution shall establish and implement a drug storage system, and adopt necessary measures such as refrigeration, and methods which prevent freezing, humidity, insects, mice, etc. so as to ensure drug quality.
Chapter 5: Drug Administration
Article 29: For new drug research and development, true data and samples regarding the method of research and development, quality parameters, results of pharmacological and toxicological experiment, etc. shall be submitted according to relevant regulations promulgated by SDA. SDA and health administration departments of the State Council (hereinafter interpreted as "MOH") shall be responsible for the promulgation of relevant regulations regarding the qualification certification drug clinical trials organizations.
SDA shall issue new drug certificates to the new drugs that have completed clinical studies and obtained approval.
Article 30: Non-clinical drug safety evaluation organizations and clinical research organizations shall respectively observe the Good Practices of Non-clinical Research of Drugs [GLP] and the Good Practice of Clinical Research of Drugs [GCP]. The Good Practices of Non-clinical Research of Drugs and the Good Practice of Clinical Research of Drugs shall be promulgated by the departments designated by the State Council.
Article 31: The manufacture of a new drug or a drug which is subject to national standards shall be approved and obtain an approval number from SDA. However, this requirement does not apply to the manufacture of TCM herbs and preparations that are not subject to approval numbers. The list of TCM herbs and preparations which shall have approval numbers shall be promulgated jointly by SDA and the TCM administration bureau of the State Council.
A drug manufacturing enterprise shall not begin manufacture until it has obtained a drug approval number.
Article 32: A drug shall comply with relevant national drug standards. TCM preparations shall comply with the requirements specified in Article 10, Provision 2 of this Law.
The Pharmacopoeia of the People's Republic of China and the drug standards promulgated by SDA shall be the national drug standards.
SDA shall organize the pharmacopoeia committee to assume the promulgation and amendments to the national drug standards.
The drug inspection organization of SDA shall be responsible for setting the standard product and comparison product.
Article 33: SDA shall organize pharmacological, medical and other relevant technical professionals to conduct evaluation of the review and assessment of new drugs, as well as re-assessment on drugs which have been approved for production.
Article 34: Drug manufacturing enterprises, drug operation enterprises and medical institutions shall purchase drugs from licensed drug manufacturing or operation enterprises. However, this is not applicable to the purchase of TCM herbs which are not regulated by means of approval numbers.
Article 35: The national government shall implement a special administration over narcotics, psychiatric drugs, toxic and radioactive drugs. The State Council shall promulgate rules.
Article 36: The national government shall implement a system to protect traditional Chinese medicines. The State Council shall promulgate rules.
Article 37: The national government shall implement an administration system for prescription and OTC drugs. The State Council shall promulgate rules.
Article 38: Drugs with uncertain medical effects, serious adverse drug reactions, or drugs hazardous to human health due to other reasons shall not be imported.
Article 39: SDA shall organize the evaluation and issuance of the registration certificates for import drugs. An import drug shall not be imported until it is confirmed according to the evaluation to be safe, efficacious and in compliance with the national drug standards and have obtained the registration certificate for import drug.
A small quantity of import drugs that are urgently needed for clinical use or just for individual self-use shall be imported according to relevant government regulations and procedures.
Article 40: Drugs shall be imported through designated ports. Enterprises which import drugs shall file the import certificate with the drug administration department in the area where the port is located. Customs shall release an import drug against the Notice to Customs for Import Drug, which is issued by the drug administration department. Customs shall not release drugs without the Notice to Customs for Imported Drug.
The drug administration departments of the area where the port for import drugs is located shall notify relevant drug inspection organizations to conduct inspection of import drugs on a random basis according to relevant regulations promulgated by SDA. The inspection fees shall be set according to the Article 41, Provision 2 of this Law.
SDA shall coordinate with the General Customs Bureau to recommend ports designated for import drugs, which shall be submitted to the State Council for approval.
Article 41: SDA shall designate drug inspection organizations to conduct the inspection on the following drugs before sale or importation, drugs that fail to pass the inspection shall not be sold or imported:
(1) biological products stipulated by SDA;
(2) drugs sold in China for the first time; and,
(3) other drugs designated by the State Council.
The inspection items and fee standards for the drugs listed above shall be jointly approved and published by public notice by the financial department and the price department of the State Council. Collection methods for the inspection fee shall be promulgated by the financial department of State Council together with SDA.
Article 42: SDA shall conduct inspections on drugs which are approved for manufacture or import. For drugs with uncertain medical effects or serious adverse reaction and drugs that may harm the human health due to other reasons, the drug administration department shall withdraw its [manufacturing] approval numbers or registration certificate for imported drug.
It is forbidden to manufacture, import, sell or use any drug whose approval number or import registration certificate is canceled; if such drugs have been manufactured or imported, they shall be destroyed or handled under the supervision of the local drug administration department.
Article 43: The national government shall implement a drug reserve system. Departments authorized by the State Council may allocate a supply of drugs from enterprises in case of the occurrence of serious disaster, epidemic disease or other sudden incidents.
Article 44: The State Council has the right to restrict or prohibit the export of drugs which are in short domestic supply.
Article 45: An Import Permit or Export Permit issued by SDA is required to import or export narcotic drugs or psychiatric drugs under government control.
Article 46: SDA shall evaluate and approve the newly discovered or introduced medicinal herbs from abroad before the herbs may be sold.
Article 47: SDA together with the TCM administration department of the State Council shall promulgate the administration methods of local commonly used folk medicinal materials.
Article 48: The manufacture or sale of counterfeit drugs (including such compounds) is prohibited.
A drug is regarded as counterfeit if it meets one of the following conditions:
(a) ingredients contained in the drug do not conform to the national drug standards;
(b) the use of a non-drug product as if it is a drug or, the use of one type of drug as if it is another kind of drug.
A drug will be regarded as a counterfeit drug if it meets one of the following conditions:
(a) the drug is banned by the administration department of the State Council;
(b) the drug is manufactured or imported without relevant approval according to this Law; or the drug is sold without being inspected as required by this Law;
(c) the drug is already deteriorated;
(d) the drug is already contaminated;
(e) the drug is made from active ingredients to which relevant government departments have not granted approval numbers as required by this Law;
(f) the drug is labeled with indications or major treatment functions which exceed the scope approved by relevant government departments.
Article 49: It is forbidden to manufacture or sell inferior drugs. A drug whose ingredients fail to conform to the requirement of the national drug standards is regarded as an inferior drug.
A drug with one of the following conditions shall be regarded as an inferior drug:
(a) the validity period of the drug is not labeled or has been altered;
(b) the production batch number of the drug is not labeled or has been altered;
(c) the drug has expired;
(d) the packing materials or container that have direct contact with the drug have not been approved;
(e) coloring agents, preservatives, spices, tasting agents or excipients are added without approval;
(f) the drug fails to comply with the drug standards.
Article 50: The drug names listed in the national drug standard are the generic drug names. The use of generic drug names as trademarks is prohibited.
Article 51: The employee of a drug manufacturing enterprise, drug operation enterprise or a medical institution who has direct contact with drugs shall undergo a health examination every year. An employee suffering from infectious diseases or other diseases which may contaminate drugs shall not engage in work that has direct contact with drugs.
Chapter 6: Administration of Drug Packaging
Article 52: Packaging materials and containers in direct contact with drugs shall meet requirements for medical use and conform to the standards to ensure the human health and safety, and shall be evaluated and approved together with drugs by relevant drug administration department.
A drug manufacturing enterprise shall not use unapproved packaging materials or containers that have direct contact with drugs.
Relevant drug administration departments shall order a stop to the use of unqualified packaging materials and containers that have direct contact drugs.
Article 53: Drug packaging shall meet relevant requirement to ensure drug quality and shall be convenient for storage, transportation and medical use.
TCM herbs shall be packaged for transportation. Each package shall be marked with the product name, place of origin, date, name of delivery and the symbol of quality certification.
Article 54: Labels shall be printed or pasted on the drug packaging, and the insert sheet shall be included in the drug packaging.
The labels or the insert sheet of a drug shall indicate the generic name, ingredients, specifications, manufacturing enterprise, approval number, product batch number, validity period, indications or major treatment functions, method of administration, dosage, contraindications, adverse drug impacts and precautions, etc.
Labels of narcotic drugs, psychiatric drugs, toxic drugs, radioactive drugs, external application drugs and OTC drugs shall have relevant required logos.
Chapter 7: Administration of Drug Pricing and Advertising
Article 55: Relevant government departments responsible to set prices and price guideline principles shall comply with the Price Law of People's Republic of China in setting or adjusting prices reasonably according to the ability of society to pay, and social average cost, market condition, in order that drug prices match quality, arbitrarily high prices are controlled, and the legitimate interests of drug consumers are protected.
Drug manufacturing enterprises, drug operation enterprises and medical institutions shall comply with the prices [or price guideline principles] set by government, and shall not arbitrarily raise drug prices.
A drug manufacturing enterprise shall honestly submit relevant material regarding its manufacturing and other business costs to relevant price administration departments. The failure to report, make a false report, or concealing information is prohibited.
Article 56: For a drug subject to free market pricing according to relevant laws, a drug manufacturing enterprise, drug operation enterprise and medical institution shall set the price for the drugs according to the following principles of "fairness, reasonableness, honesty, price based on quality", and provide drug consumers with reasonably priced drugs.
Drug manufacturing enterprises, drug operation enterprises and medical institutions shall observe relevant drug administration regulations promulgated by the relevant departments of the State Council responsible for price affairs to set and clearly mark drug retail prices. The making of exorbitant profits and conducting fraud in the pricing of drugs to damage the interest of drug consumers is prohibited.
Article 57: Drug manufacturing enterprises, operation enterprises and medical institutions shall provide relevant price administration departments with actual drug transaction prices and volumes, etc.
Article 58: A medical institution shall provide patients with a price list of drugs used. A designated medical institution for medical insurance shall publicize the prices of drugs in common use according to relevant regulations and strengthen the administration of reasonable drug use. MOH shall formulate relevant regulations.
Article 59: Drug manufacturing enterprises, operation enterprises and medical institutions are prohibited from providing and accepting kick-backs or other material benefits not included in accounting records during the process of drug transactions.
The providing of material benefits and other benefits to the responsible persons of medical institutions, drug purchasers, doctors or other relevant persons working in a medical institution by drug manufacturing enterprises, operation enterprises or their agents is prohibited. The acceptance of material benefits and other benefits responsible persons, drug purchasers, doctors or other relevant persons working in a medical institution offered by drug manufacturing enterprises, other enterprises or their agents is prohibited.
Article 60: The drug administration department of the people's government of the province, autonomous region or municipal city where the enterprise is located shall approve and issue an approval number for a drug advertisement. The publishing of a drug advertisement without the approval number is prohibited.
Prescription drugs may be introduced on professional medical and pharmacological journals co-designated by MOH and SDA, but shall not be promoted by publishing advertisement via mass media nor by conducting any other form of promotional activities targeted at the public.
Article 61: The contents of a drug advertisement shall be truthful and legitimate, conform to the insert sheet of the drug as approved by SDA, and shall not include any false contents.
A drug advertisement shall not contain any non-scientific assertion or guarantee regarding the efficacy of drugs, shall not use the reputation or images of any government department, pharmaceutical research unit, academic research institutions or any individual such as an expert, scholar, doctor or patient as evidence.
A non-drug advertisement shall not involve promotion of any drugs.
Article 62: Drug administration departments of people's government of provinces, autonomous regions and municipal cities shall inspect the drug advertisements they have approved, and shall inform relevant advertisement administration department of any violation of the Advertisement Law of the People's Republic of China and make proposals regarding the handling of any violation. Relevant advertisement administration departments shall handle the violation according to law.
Article 63: The Price Law of the People's Republic of China and Advertisement Law of the People's Republic of China shall be applicable to any drug price and advertisement issues that are not covered by this Law.
Chapter 8: Supervision of Drugs
Article 64: Drug administration departments are authorized to supervise and inspect relevant activities of drug research and development, manufacturing, distribution, and drug use by medical institutions which are subject to its approval according to relevant laws and regulations. The concerned units and individuals shall not refuse to provide and shall not conceal any information.
A drug administration department shall present relevant certificates in conducting inspections, and shall maintain the confidentiality of any technology and business secrets learned during inspection.
Article 65: A drug administration department may conduct random quality inspection on drugs according to relevant requirements of administration. Samples taken during random inspections shall be according to relevant regulation, and a fee shall not be charged for such samples. Costs accrued during inspection shall be recorded and allocated according to relevant regulation of the State Council.
A drug administration department may adopt mandatory administrative measures to seal and retain drugs and other relevant drug materials which evidence possible harms human health. The drug administration department shall make relevant administrative decisions within seven days. Should the drug be tested, the administration decision shall be made with fifteen days from the delivery of the test report.
Article 66: SDA and drug administrative departments of provinces, autonomous regions and municipal cities shall periodically announce the results of random inspection through public notice. Any inappropriate announcement shall be clarified within the scope of the original public notice.
Article 67: Should a party object to a test result delivered by a drug testing institution, it may apply for a re-test with the original drug inspection organization or with the designated drug inspection organization at a higher level within seven days upon the receipt of the test report. The party may also directly apply for a re-test to the drug inspection organization designated by SDA. The drug inspection organization accepting the application must obtain the re-test result within the time specified by SDA.
Article 68: A drug administration department shall conduct follow-up inspections according to GMP and GSP on drug manufacturing and operation enterprises that have received quality certificate from it.
Article 69: Local people's government and drug supervision and administration departments are forbidden to adopt any methods, such as requiring drug testing or application for approval etc., to restrict or exclude drugs manufactured according to this Law by non-local enterprises from entering into the local market.
Article 70: Drug administration departments and their drug inspection organizations and their other designated specialized drug inspection departments shall not participate in the drug manufacturing and operation activities, or recommend drugs or supervise drug manufacturing or operations.
Employees of drug administration departments and their drug inspection organizations and their other designated specialized drug inspection departments shall not participate in drug manufacturing and operation activities.
Article 71: The national government shall implement a monitoring system of adverse drug reactions. Drug manufacturing enterprises, operation enterprises and medical institutions shall frequently inspect the quality, efficacy and medical effects of the drugs. Any serious adverse reactions shall be duly reported to the local drug administration department and the health administration department of the people's government of the province, autonomous region or municipal city. Relevant regulations shall be promulgated by SDA together with MOH.
For a drug that is confirmed to have serious drug reactions, SDA or the drug administration departments of the provinces, autonomous regions and municipal cities may adopt emergency measures to stop the manufacture, sale and use of the drug, and organize relevant experts to evaluate within five days. The administrative decision shall be according to relevant laws, and made within fifteen days from the delivery of evaluators' determination.
Article 72: Drug inspection departments and employees of drug manufacturing enterprises, drug operation enterprises and medical institutions shall accept professional guidance from the drug inspection organizations of local drug administration departments.
Chapter 9: Legal Responsibilities
Article 73: In accordance with relevant laws, any drug manufacturing or drug transaction activities conducted without the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or License for Medical Institution to Make Preparations shall cease, drugs illegally manufactured and the income derived from them shall be confiscated, and a fine imposed between 2 to 5 times the value of the illegally manufactured or sold drugs (including unsold).. Violations of criminal law shall be prosecuted.
Article 74: For a counterfeit drug, illegal income from its manufacture or sale shall be confiscated, a fine imposed between 2 to 5 times the value of the illegally manufactured or sold drugs, the drug approval document cancelled, and an order issued ceasing manufacturing and selling activities until the situation is remedied. In a serious case, the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or Medical institution Medicament Compounding shall be canceled. Violations of criminal law shall be prosecuted.
Article 75: For an inferior drug manufactured illegally, the income derived shall be confiscated, a fine shall be imposed between 1 to 3 times the value of the inferior drug manufactured or sold. In a serious case, an order shall be issued to cease manufacturing and selling activities until the situation is remedied, or cancel the drug approval document, and the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or License for Medical Institution to Make Preparations. Violations of criminal law shall be prosecuted.
Article 76: In serious cases, persons directly in charge or otherwise directly responsible in enterprises or units engaged in the manufacture or sale of counterfeit drugs or inferior drugs shall be prohibited from engaging in drug manufacturing and operation activities for 10 years.
Raw materials, excipient, packaging materials or manufacturing facilities specifically used in the manufacture of counterfeit and inferior drugs shall be confiscated.
Article 77: Illegal revenues derived from providing transportation, custody, or storage to drugs one knows or should know are counterfeit or inferior shall be confiscated, and a fine imposed in the amount of between 50% to 3 times of the illegal income. Violations of criminal law shall be prosecuted.
Article 78: Any notice containing sanctions for counterfeit or inferior drugs shall include the quality testing results of the drug testing institution. However, this is not applicable to situations described in Article 48, Provision 3, Items (1), (2), (5), and (6) and Article 49, Provision 3 of this Law.
Article 79: Drug manufacturing enterprises, drug operation enterprises, drug non-clinical safety evaluation and research institutions, and drug clinical trial institutions which fail to implement GMP, GSP, GLP, and GCP, shall be warned and instructed to remedy the violations within a certain time. Those which refuse or fail to remedy the violations within the required time shall be ordered to stop drug manufacture or operations until the violation is remedied, and shall be fined between 5,000 to 20,000 RMB. In a serious case, the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or the certification for qualifying as a clinical test institution of drugs shall be canceled.
Article 80: Drug manufacturing enterprises, drug operation enterprises or medical institutions which, in violation of Article 34 of this Law, purchase drugs from units without License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise, shall be ordered to remedy the situation, the illegally purchased drugs shall be confiscated, and a fine imposed between 2 to 5 times the value of purchase. Illegally derived income shall be confiscated. In a serious case, the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or the Business License of Medical Institution shall be canceled.
Article 81: Any unit which, in importing a drug with an Import Permit, fails to register with drug supervision and administration departments at the location of the port of entry in accordance with requirements of this Law, shall be given a warning and ordered to remedy the violation within a certain time. For those which refuse or fail to remedy the violation within the required time, the Import Permit shall be canceled.
Article 82: Illegal income obtained from forging, modifying, trading, leasing or lending licenses or other approval documents of drugs shall be confiscated, a fine shall be imposed between 1 to 3 times of the illegal income. In there is no illegal income, a fine between 20,000 to 100,000 RMB shall be imposed. In a serious case, the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise, or License for Medical Institution to Make Preparations held by the selling, leasing, or lending party shall be canceled, or drug approval documents canceled. Violations of criminal law shall be prosecuted
Article 83: A License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise, or License for Medical Institution to Make Preparations or other drug approval documents obtained in violation of this Law, by submitting false certificates or documents or, by other fraudulent measures, shall be canceled. Another application shall not be accepted within 5 years. A fine between 10,000 to 30,000 RMB shall be imposed.
Article 84: Medical institutions shall be ordered to remedy violation of selling their own preparation in the market. The illegally sold preparations shall be confiscated. A fine shall be imposed 1 to 3 times the value of the preparation. If there is illegally derived income, it shall be confiscated.
Article 85: Drug operation enterprises which violate Article 18 and Article 19 in this Law shall be ordered to remedy the situation, and be warned. In a serious case, the License for Drug Operation Enterprises shall be canceled.
Article 86: Drugs with labels that do not comply with Article 54 of this Law shall be treated as counterfeit or inferior drugs. In addition, the drug manufacturing and operation enterprises shall be ordered to remedy the situation. In a serious case, the approval documents of the drug shall be canceled.
Article 87: For the issuance of a false test report which constitutes a crime, a drug testing institute shall be criminally prosecuted. For a non-criminal violation, the drug testing institutions shall be warned and ordered to remedy the situation. A fine between 30,000 and 50,000 RMB shall be imposed. Persons directly in charge and other directly responsible persons shall be demoted, released from positions and fined less than 30,000 RMB. Illegal income shall be confiscated. In a serious case, the certification of qualification for drug testing shall be canceled. If the drug testing institution provides a false testing report which results in loss, then the unit shall be corresponding liable.
Article 88: A drug administration departments above the county level shall decide which administrative sanctions listed in Articles 73 to 87 in this Law shall be imposed within its respective authority delegated by SDA. Decisions to cancel the License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise, License for Medical Institution to Make Preparations or the Business License of Medical Institution or drug approval documents shall be made by the original issuing and approval departments.
Article 89: Violation of the regulations of drug price administration as specified in Articles 55, 56 and 57 in this Law, shall be handled according to the relevant regulations promulgated under the Price Law of the People's Republic of China.
Article 90: Drug manufacturing enterprises, drug operation enterprises and medical institutions that covertly provide or accept kick-backs or other material benefits in drug procurement and selling activities; drug manufacturing enterprises, drug operation enterprises or their agents that provide persons in charge, drug purchasing personnel, doctors or other related personnel working in medical institutions which use their drugs with material property or other benefits shall be fined between 10,000 to 200,000 RMB by the industrial and commercial administration departments. Illegally derived incomes shall be confiscated. If the case is serious, the industrial and commercial administration department shall cancel the business license of the drug manufacturing enterprises and drug operation enterprises, and inform the drug administration department which shall cancel its License for Drug Manufacturing Enterprise, or License for Drug Operation Enterprise. Violations of criminal law shall be prosecuted.
Article 91: Responsible persons, purchasing personnel and other relevant personnel in the drug manufacturing and operation enterprises who accept material properties or benefits offered by other manufacturing and operation enterprises or their agents shall be punished in accordance with relevant laws. Illegal derived income shall be confiscated. Violation of criminal law shall be prosecuted.
Responsible persons, drug purchasing personnel, doctors or other relevant personnel working in medical institutions who accept material properties or benefits provided by drug manufacturing enterprises, drug operation enterprises or their agents shall be disciplined through measures adopted by the health administration department or the local units and illegally derived income shall be confiscated. In a serious case involving a certified doctor, the doctor's certification shall be canceled by the health administration department.
Article 92: Any unit or individual violating the regulations of drug advertising administration shall be punished according to the Advertisement Law of the People's Republic of China, and the drug administration department which issued the advertisement approval number shall cancel the approval number and shall refuse the advertisement approval application for the drug. Violations of criminal law shall be prosecuted.
If drug administration departments do not perform their duties to check drug advertisements and an approved advertisement has fraudulent or illegal contents, then the persons directly in charge or others directly responsible shall be administratively disciplined. Violations of criminal law shall be prosecuted.
Article 93: If a drug manufacturing enterprise, drug operation enterprise or medical institution violates this Law in causing harm to a drug user, the drug manufacturing enterprise, drug operation enterprise and medical institution shall be liable for compensation.
Article 94: When the drug administration departments violate this Law, in the following circumstances, the superior level department or the supervision agency shall issue orders to revoke any certificates, or approval documents for drugs issued in violation of law. The person in charge or other persons directly responsible shall be administratively disciplined. Violations of criminal law shall be prosecuted.
(a) Issuance of certification to the enterprises that don't comply with the GMP, GSP or failure to perform the duties of checking enterprises that have been given certificates in accordance with relevant regulation or failure to order enterprises not complying with the certification conditions to correct errors or cancel the certification;
(b) Issuance of License for Drug Manufacturing Enterprise, License for Drug Operation Enterprise or License for Medical Institution to Make Preparations to units which do not meet legal requirements;
(c) Issuance of registration certificate for drugs which do not meet import requirements;
(d) Issuance of new drug certificate, drug approval number or approval to conduct clinical trial to units which do not meet clinical trial requirements or manufacturing requirements.
Article 95: Drug administration departments or the drug testing institution identified by the drug administration departments or other institutions which specialized in drug testing and designated by the drug administration departments shall be ordered by its superior organization or the state supervision agency to cease engaging in drug manufacturing and operation activities, and illegal revenues shall be confiscated; in a serious case, the person directly in charge or other persons who are directly responsible shall receive administrative discipline.
Persons working in drug administration departments and the drug testing institution established by the drug administration departments or other institutions which specialized in drug testing and designated by the drug administration department are prohibited from engaging in drug manufacturing and operation activities. Violations will be administratively disciplined.
Article 96: Relevant government departments shall order the return of any illegally collected test fees by the drug administration departments or by their designated testing institutions in the course of administering and testing of drugs. The person directly in charge and other persons who are directly responsible shall receive administrative discipline. In a serious case of illegally collecting testing fees by drug testing institutions, their certification shall be canceled.
Article 97: Drug administration departments shall execute their supervision and inspection functions to impose supervision over the manufacturing or operation activities of enterprises which have obtained the License for Drug Manufacturing Enterprise, or License for Drug Operation Enterprise and ensure that their activities are conducted in accordance with this Law.
In addition to an enterprise with License for Drug Manufacturing Enterprise or License for Drug Operation Enterprise being legally liable if it engages in production or sales of counterfeit drugs or drugs of inferior quality, person directly in charge or other persons directly responsible in the drug administration departments who abuse their power or are negligent shall receive administrative discipline. Violations of criminal law shall be prosecuted.
Article 98: Drug administration departments shall order their subordinate drug administration departments to correct administrative acts which violate this Law within a certain time; and shall have the right to change or revoke the order if the violation is not duly corrected.
Article 99: Drug administration personnel shall be liable if they violate this Law by abuse of power or neglect of duty. Violations of criminal law shall be prosecuted, other violations shall be administratively disciplined.
Article 100: Drug administration departments shall inform the department of administration of industry and commerce to modify or cancel the registration of an enterprise which License for Drug Manufacturing Enterprise or License for Drug Operation Enterprise has been canceled in accordance with this Law.
Article 101: The value of drugs in this Chapter shall be calculated according to the retail prices marked on packaging of the drugs illegally manufactured or sold; if there is no retail price, the value shall be calculated according to the market price of the same type of drugs.
Chapter 10: Miscellaneous
Article 102: The following terms are defined as:
Drug: refers to materials that are used in prevention, treatment, or diagnosis of diseases and purposeful readjustment of the biological functions of the human body with specified indications, functions, means of administration and dosage quantity, including TCM herbs, TCM preparations, finished TCM, bulk chemicals and their preparations, antibiotics, biochemical drugs, radioactive drugs, serums, vaccines, blood products, diagnostic drugs, etc.
Excipient: refers to excipient or additive agent used in compounding preparations or prescriptions.
Drug Manufacturing Enterprise: refers to an enterprise which manufactures drugs on an exclusively or non-exclusive basis.
Drug Operation Enterprise: refers to an enterprise which engages in drug distribution on an exclusive or non-exclusive basis.
Article 103: Administration methods governing the cultivation, collection and breeding of the materials for traditional Chinese medicines shall be separately promulgated by the State Council.
Article 104: The government exercises special administration on the distribution of preventative biological products. The specific measures are to be promulgated by the State Council.
Article 105: The specific implementation methods of this Law for the PLA shall be promulgated by the State Council and the Central Military Committee in accordance with this Law.
Article 106: This Law shall be effective from December 1, 2001.
