(Temporary Regulation)
(SDA, Guo Yao Guan Zhu [2000] No. 12)
(Effective May 1, 2000)
Article 1: General Principles
1.1 This "Drug Registration Procedure" (Temporary Regulation, hereinafter "Procedure") is promulgated in order to strengthen drug registration administration, standardize registration procedure, protect the legitimate interests of the drug registration applicant, and ensure the fairness and efficiency of drug registration authorities and their staff.
1.2 This Procedure applies to the registration of new drugs, imported drugs, generics, etc.
1.3 A drug registration applicant (hereinafter "applicant") and drug registration authorities at all levels and their staff shall abide by this Procedure.
Article 2: Drug Registration Authorities and Their Responsibilities
2.1 The State Drug Administration (hereinafter "SDA") is the competent authority for drug registration administration throughout China. The Drug Registration Department of SDA shall represent SDA in accepting applications, delegating evaluation of applications, approving applications, issuing licenses, and administering drug registration work.
2.2 The drug administration departments of each province, autonomous region and municipal city are responsible for accepting drug registration applications of new drugs, generics within their jurisdiction, and completing an initial examination (unless other national laws apply).
2.3 The Drug Evaluation Center of SDA (hereinafter "Drug Evaluation Center") is the technical evaluation organization of the State Drug Administration for drug registration. Under the leadership of the Drug Registration Department, the Drug Evaluation Center shall conduct a technical evaluation of new drugs, import drugs and generics, and prepare a comprehensive evaluation recommendation for submission to the Drug Registration Department for approval.
2.4 Drug evaluation experts of SDA are responsible for providing advisory technical evaluation opinions for new drugs (including new biological products), imported drugs and generics. SDA shall select the experts at random from "Bank of State Drug Evaluation Experts" to participate in evaluation meetings.
2.5 The National Institute for the Control of Pharmaceuticals and Biological Products ("NICPBP") is responsible for the technical laboratory examination of Class 1 new drugs and new biological products. Provincial drug inspection institutes are responsible for technical laboratory examination of Class 2-5 new drugs and generics within their jurisdiction.
2.6 Coastal Drug Inspection Institutes are responsible for the technical laboratory examination of import drugs.
Article 3: Initial Examination of the Application for Drug Registration
3.1 For a drug that will be initially examined by provincial drug administration departments, the applicant shall submit a completed application form to the respective provincial drug administration department together with required technical data and samples.
3.2 The provincial drug administration department shall examine the application according to relevant regulations concerning drug evaluation. Incomplete applications shall be returned to the applicant. For applications with complete materials, a formal Notice of Acceptance (See Appendix) shall be prepared and provincial drug inspection institutes shall be assigned to conduct the technical laboratory examination. After payment of the evaluation fee, the drug administration department shall: verify the authenticity, integrity, and standardization of the original data; inspect the development site of the drug; and organize a technical evaluation and prepare an initial evaluation opinion. An application which meets the requirements shall be submitted to the Drug Registration Department. For an application which does not meet requirements, it shall be determined whether to ask for supplementary data or reject the application. Applicants shall provide supplementary materials according to the requirements to the provincial drug administration department for evaluation. An application which meets the requirements will be submitted to the Drug Registration Department.
3.3 Each provincial drug administration department shall promulgate its own procedure for initial evaluation of new drugs based on local conditions while referring to this Procedure and file its procedure with the Drug Registration Department.
3.4 Time limits for initial evaluation by provincial drug administration department: 3.4.1 Normally, the initial evaluation of new drugs and generics shall not exceed 100 days from the date of issuance of the Notice of Acceptance, during which time provincial drug inspection institutes shall conduct a technical laboratory examination not to exceed 60 days, and the examination of supplementary materials shall not exceed 30 days.
3.4.2 If accelerated procedures are used for new drugs and new biological products, evaluation of the original data and inspection of site of the development site shall not exceed 30 days.
3.4.3 The initial evaluation of generics shall usually not exceed 15 days.
Article 4: SDA Re-examination of an Application for Drug Registration
4.1 Upon receipt of an application already initially approved by a provincial drug administration department, the Drug Registration Department shall examine it for form to ensure it is standardized and complete. A Notice of Acceptance to and invoice for the examination fee shall be issued. Upon receipt of payment, the application materials shall be sent to the Drug Evaluation Center to conduct a technical evaluation. An application which does not meet the requirements shall be returned to the provincial drug administration departments.
4.2 According to the Regulation for the Approval of New Drugs, SDA is responsible for accepting application for and organization of the evaluation of: Class 1 chemical drugs, Class 1 new TCM, TCM with changed-dosage-form for which the confidentiality class is already determined according to the State Confidentiality Law, the addition of indications for a drug, and new biological products. The applicant shall first apply for a technical laboratory examination by NICPBP, and concurrently make written application to the provincial drug administration department for examination of the original materials and inspection of the drug development site. Upon completion of the above work showing the application requirements have been met, the provincial drug administration department shall seal the application form, materials, evaluation results and inspection report and submit them to the Drug Registration Department. The Drug Registration Department shall examine for form the submitted application to ensure it is standardized and complete. The Drug Registration Department shall send a Notice of Acceptance and invoice for examination fee to an applicant meeting the requirements, and upon receiving payment, transfer the application materials to the Drug Evaluation Center to conduct a technical evaluation. An application which does not meet the requirements shall be returned to the applicant.
Article 5: The Technical Evaluation as Part of SDA's Re-examination
5.1 The technical evaluation as part of SDA's re-examination of the drug registration application includes the technical evaluation by the Drug Evaluation Center, expert evaluation meetings, solicitation of written opinions of experts and necessary technical laboratory evaluations by drug inspection institutes.
5.2 The Drug Evaluation Center shall duly conduct a complete technical evaluation of the application material. In principle, the supplementary materials that are required shall be combined into one notice that is issued within the time limit for review and copied to the department which conducted the initial examination. The applicant shall submit the required supplementary materials to the Drug Evaluation Center and provide a copy to the provincial drug administration department. If the supplementary materials are not sufficient, the Drug Evaluation Center may request further materials.
5.3 SDA shall organize regular, and as needed, expert evaluation meetings. Expert evaluation meetings for the registration of new drugs and imported drugs will usually be held each May and September, and quarterly meetings will be held for the renewal of import drug certificates. The Drug Evaluation Center is responsible for preparing a list of drugs and technical questions for which expert opinion is needed, randomly selecting experts, drafting meeting agenda to be approved by the Drug Registration Department, and preparation of all meeting matters including budget, meeting documents, etc.
5.4 The Drug Evaluation Center shall collect and organize experts' opinions about the drugs discussed in drug evaluation meetings, prepare and submit to the Drug Registration Department a comprehensive evaluation recommendation based both on experts opinions and on the technical evaluation by the Drug Evaluation Center.
5.5 When there is difference of opinion concerning drug evaluation between the Drug Evaluation Center and the experts evaluation committee or, between the Drug Registration Department and Drug Evaluation Center, the other party shall be informed of the final decision.
5.6 New drugs and imported drugs selected to be discussed in periodic evaluation meetings are:
5.6.1 those new drugs for which application has been officially accepted and the evaluation fee received at least 50 days before evaluation meeting, and the technical evaluation has been completed by the Drug Evaluation Center at least 30 days before the meeting;
5.6.2 those import drugs for which the application for an import renewal certificate has been officially accepted, and the evaluation fee has been received at least 25 days before the evaluation meeting; and
5.6.3 other drugs which need accelerated evaluation.
5.7 Additional evaluation meetings may be held for the following drugs:
5.7.1 Class 1 new drugs (including Class 1 biological products);
5.7.2 TCM with changed-dosage-form for which the confidentiality class has already been determined according to the State Confidentiality Law, or the addition of indications for a drug;
5.7.3 biological products and chemical drugs for which clinical research has been registered for the first time; and
5.7.4 other drugs that need to be evaluated.
A drug referred to above shall not be listed and discussed in evaluation meetings until its technical evaluation has been completed by the Drug Evaluation Center, application documents meet relevant requirements and approval from the Drug Registration Department has been obtained.
5.8 Supplementary laboratory research for reexamination requested by the experts evaluation committee shall be examined by the Drug Evaluation Center or the expert evaluation committee as determined by the expert evaluation committee.
5.9 Supplementary materials which further explain or provide documentary evidence of the technical data of an application shall be evaluated by the Drug Evaluation Center.
5.10 Upon receipt of the notice requesting supplementary materials from the Drug Evaluation Center, the applicant shall submit all requested material at one time before the deadline, otherwise the application shall be regarded as automatically withdrawn.
Article 6: Approval of the Drug Registration Application
The Drug Registration Department shall examine the comprehensive evaluation recommendation from the Drug Evaluation Center and other relevant materials according to relevant regulations and submit to SDA leaders for approval any application which meets the requirements.
Article 7: Time Limits for Reexamination of the Drug Registration Application
7.1 Time limits to examine for form the application documents:
7.1.1 normally shall not exceed 12 days for new drugs and generics;
7.1.2 normally shall not exceed 7 days when accelerated evaluation procedure is adopted; and,
7.1.3 normally shall not exceed 30 days for imported drugs.
7.2 Time limits for technical evaluation by the Drug Evaluation Center:
7.2.1 New drugs
The Accelerated procedures (including the accelerated review process for certain drugs)
In the accelerated procedure, the evaluation of application materials shall be completed within 30 days. For a drug whose review process shall be accelerated [See Regulation for The Approval of New Drugs, Articles 26 and 27], evaluation of application documents shall be completed within 60 days with a recommendation for handling the application; a comprehensive recommendation shall be prepared within 15 days for a drug evaluated at an experts evaluation meeting. An application which meets requirements shall be submitted for approval. For an application which does not meet the requirements, a recommendation shall be made to request the submission of further materials or, to reject the application.
Generally, the evaluation of supplementary materials for drugs under accelerated procedures shall be completed within 15 days.
For an application which the Drug Registration Department returns to the Drug Evaluation Center for further modification or supplementary evaluation recommendation, the Drug Evaluation Center shall complete the work and re-submit it to the Drug Registration Department within 3 days, under exceptional circumstances, within 10 days.
Normal procedure
The Drug Evaluation Center shall complete a technical evaluation within 180 days upon receipt of the application material from the Drug Registration Department, evaluation of supplementary materials shall be completed within 120 days. When further explanation or documentary proof is needed, the evaluation shall be completed within 30 days.
The Drug Evaluation Center shall prepare a comprehensive evaluation recommendation and approval documents for an application meeting requirements, and submit it for approval within 60 days after the expert evaluation meeting. The Drug Evaluation Center shall request supplementary materials for an application not meeting requirements, or reject the application.
For a drug for which trial production has already been approved, the evaluation of the transfer materials to permanent status and of the supplementary application shall be completed within 60 days.
For an application that is rejected by the Drug Registration Department and returned to the Drug Evaluation Center for further modification or supplementary evaluation recommendation, the Drug Evaluation Center shall complete the work and re-submit it to the Drug Registration Department within 10 days, under exceptional circumstances, within 30 days.
7.2.2 Generics
The Drug Evaluation Center shall prepare a comprehensive evaluation recommendation and approval documents for an application meeting requirements, and submit it for approval within 80 days. The Drug Evaluation Center shall request supplementary materials for an application not meeting requirements or, reject the application.
7.2.3 Import Drug
For an application meeting requirements, the Drug Evaluation Center shall prepare a comprehensive evaluation recommendation, and a "Notice of Experts Evaluation Recommendation on Import Drug" and submit it for Approval within 60 days after the experts evaluation meeting.
Upon the receipt of clinical trial protocol from the applicant and the results of quality re-examination, the Drug Evaluation Center shall prepare a "Approval Documents for Clinical Study of Import Drug" within 30 days and submit it to the Drug Registration Department for approval.
The Drug Evaluation Center shall prepare a comprehensive evaluation recommendation for an import drug within 60 days upon the completion of clinical experiment and receipt of supplementary materials, and submit it to the Drug Registration Department for approval.
7.3 Time limits for technical laboratory examination by provincial drug inspection institutes:
7.3.1 Examination of laboratory technical data for a new drug (including biological products) by NICPBP shall not exceed 100 days, and, the examination of an vaccine shall not exceed 150 days.
7.3.2 Examination of laboratory technical data by Coastal Drug Inspection Institutes should be completed within the time limits stipulated in the "Regulation for Administration of Imported Drug".
7.4 Time limits for evaluation and approval by SDA:
7.4.1 The evaluation and approval of an application of generic registration normally shall not exceed 50 days.
7.4.2 Upon the receipt of the submitted comprehensive recommendation and approval documents for a new drug, import drug, or generics from the Drug Evaluation Center, the evaluation and approval by the Drug Registration Department normally shall not exceed 40 days, and when accelerated evaluation procedures have been adopted, it shall not exceed 12 days.
7.4.3 Normally, the Director General of SDA shall sign and ratify the approval within 20 days, and 12 days when accelerated evaluation procedures have been adopted.
7.4.4 The license and the approval document for a new drug, an import drug, or a generic shall be prepared within 20 days upon the receipt of the approval from the Director General, and within 5 days for a new drugs whose review process has been accelerated.
Article 8: Reconsideration
When an application for registration is not approved, the applicant may apply for reconsideration to the Administrative Reconsideration Office of SDA according to relevant regulations.
Article 9: Miscellaneous
9.1 Time limits described in this Procedure shall be calculated according to calendar days.
9.2 Re-examination of an application of drug registration shall be conducted within the time limits defined in the above provisions. It may be prolonged under exceptional circumstances.
9.3 The time limits stipulated in this Procedure do not include the time needed by an applicant, after receiving the notice from the evaluation organizations, to conduct supplementary experiments and prepare supplementary material, etc. (The date of the post mark or signature of receipt is the official date of notice).
9.4 SDA is responsible for the interpretation of this Procedure.
For "NOTICE OF ACCEPTANCE OF NEW DRUG REGISTRATION APPLICATION", Please Click here.
For "NOTICE OF ACCEPTANCE OF GENERICS REGISTRATION APPLICATION", Please Click here.
