Provisions for Drug Registration

Chapter VII Working Timeline

Article 94 The drug registration timeline mentioned in these Provisions is the longest time needed for drug registration acceptance, review, inspection, testing, approval, etc. The timeline for priority review and approval procedures shall be implemented in accordance with relevant provisions on priority review and approval.

The CDE and other specialized technical institutions shall clarify their own working procedures and timelines to the public.

Article 95 Upon receiving a drug registration application, the drug regulatory department shall conduct preliminary review and, within 5 days, make a decision of acceptance, supplement and correction or rejection.

Article 96 Drug registration review is subject to the following timelines:

(1) The timeline for review and approval of drug clinical trial applications and supplementary applications submitted during clinical trials is 60 days.

(2) The review timeline for drug marketing authorization applications is 200 days; the review timeline of priority review and approval procedures is 130 days; the review timeline of priority review and approval procedures for rare disease drugs with urgent clinical needs which have been marketed overseas is 70 days.

(3) The review timeline for independent applications of generic products of domestically marketed chemical active drug ingredients is 200 days.

(4) The review timeline for supplementary applications of changes subject to approval is 60 days; the review timeline for supplementary applications combined with application items is 80 days. Where clinical trial data review and inspection, drug registration inspection and testing are involved, the review timeline is 200 days.

(5) The timeline for approval of adopted name is 30 days.

(6) The timeline for non-prescription drugs eligibility review is 30 days.

The timeline for bundling review is the same as that for the review of the corresponding drug product.

Article 97 Drug registration inspection is subject to the following timelines:

(1) The CDE shall, within 40 days upon acceptance of a drug registration application, notify the CFDI to initiate inspection and, at the same time, inform the applicant;

(2) The CFDI shall, in principle, complete inspection of the drug registration manufacturing site 40 days prior to expiration of the review timeline, and provide feedback of the inspection situation, inspection results and other relevant documents to the CDE.

Article 98 Drug registration testing is subject to the following timelines:

(1) The timeline for sample testing is 60 days; the timeline for simultaneous sample testing and specification verification is 90 days;

(2) The timeline for providing supplementary dossier during drug registration testing is 30 days.

(3) Drug testing institutions shall, in principle, complete the drug registration testing at least 40 days prior to expiration of the review timeline, and deliver the drug specification verification comments and testing report to the CDE.

Article 99 The timeline for the review and approval of drug registration renewal is 120 days.

Article 100 A decision on administrative approval shall be made within 20 days.

Article 101 The drug regulatory department shall issue and serve relevant administrative approval certificates within 10 days as of the date when the drug registration review and approval decision is made.

Article 102 Where it is necessary to extent the timeline due to product characteristics and special circumstances in review, inspection and/or testing, the extension shall not be longer than 1/2 of the original timeline. After the extension is approved by the person in charge of a technical institution for drug review, inspection or testing, the technical institution which extends the timeline shall inform the applicant in a written notice and notify other relevant technical institutions.

Article 103 The following time shall not be included into the drug registration timeline:

(1) Time needed for the applicant to supplement dossiers, make rectification after inspection and verify the manufacturing process, specifications and package inserts as required;

(2) Delays in conducting inspection, testing and holding expert advisory meetings caused by the applicant.

(3) Time occupied during suspension of the review and approval procedures where the review and approval procedures are suspended in accordance with laws and regulations.

(4) Time occupied during overseas inspection where overseas inspection is initiated.

Chapter VIII Supervision and Administration

Article 104 The NMPA shall be responsible for the supervision, management, appraisal, and guidance of tasks related to drug registration administration undertaken by the CDE and other relevant specialized technical institutions and drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.

Article 105 Drug regulatory departments shall, in accordance with laws and regulations, supervise and inspect drug R&D activities and, when necessary, carry out extended inspection of entities and individuals providing products or services for drug R&D. Relevant entities and individuals shall provide cooperation and shall not refuse inspection or conceal information.

Article 106 The NMPAIC is responsible for establishing drug product master file, managing the drug coding system, collecting and continually updating information on drug registration applications, safety-related reports during clinical trials, review, inspection, testing, approval, as well as approval, filing and report for post-marketing changes, etc. Relevant regulations on drug product master file and code-based management shall be formulated and published by the NMPAIC.

Article 107 Drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall perform routine GLP and GCP inspections of drug non-clinical safety evaluation and research institutes, drug clinical trial organizations and other research institutions to ensure their continuous compliance with statutory requirements. The NMPA may initiate supervision and inspection of drug non-clinical safety evaluation and research institutes, drug clinical trial organizations and other research institutions as needed.

Article 108 The NMPA establishes the drug safety credit management system, and the CFDI is responsible for establishing the drug safety credit record for drug non-clinical safety evaluation and research institutes and drug clinical trial organizations, recording license issuance, routine supervision and inspection results, and investigation and handling of illegal acts, disclosing the records to the public in accordance with the law and updating records in a timely manner. For entities with poor credit records, the drug regulatory departments shall increase the supervision and inspection frequency and may impose joint punishment according to national regulations. Relevant provisions for the drug safety credit record of drug non-clinical safety evaluation and research institutes and drug clinical trial organizations shall be formulated and issued by the CFDI.

Article 109 The NMPA shall, in accordance with the law, disclose to the public the list for drug registration review and approval items and its legal bases, the review and approval requirements and timeline. Drug registration progress shall be disclosed to the applicants. The NMPA shall disclose to the public review conclusions and basis for approved drugs as well as illegal acts discovered in supervision and inspection, and accept public supervision.  

Package inserts of approved drugs shall be disclosed to the public and promptly updated. For vaccines, the content of labels shall also be disclosed and promptly updated.

Without consent from the applicant, drug regulatory departments, specialized technical institutions and their staff, and participants in expert review shall not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant, except as otherwise provided by law or those involving national security and major social and public interests.

Article 110 In any of the following circumstances, the NMPA shall revoke the Drug Approval License, and disclose the information:

(1) Where the MAH requests to cancel its own Drug Approval License;

(2) Where registration shall not be renewed according to these Provisions;

(3) Where the MAH's Drug Approval License, Drug Manufacturing Certificate and other administrative licenses have been revoked or withdrawn in accordance with the law;

(4) Where, according to provisions in Article 83 of the Drug Administration Law, drugs have uncertain efficacy and serious adverse reactions or are otherwise harmful to human health;

(5) Where, according to the provisions in Article 61 of the Vaccine Administration Law, vaccines have serious adverse events following immunization or are otherwise harmful to human health as indicated by post-marketing evaluation;

(6) Where, according to the provisions in Article 62 of the Vaccine Administration Law, the variety is found in post-marketing evaluation to be significantly inferior to other vaccines used for the preventing and control of the same disease in terms of product design, manufacturing process, safety, efficacy or quality;

(7) Where, against the provisions of laws and administrative regulations, relevant studies have not been completed within the specified timeline as required in the Drug Approval License or by the drug regulatory departments;

(8) Other circumstances where the Drug Approval License shall be cancelled according to law.

Chapter IX Legal Liabilities

Article 111 Where an applicant obtains the clinical trial permit or Drug Approval License by providing false certificates, data, documents or samples or by other fraudulent means during the drug registration process, the case shall be handled according to Article 123 of the Drug Administration Law.

Article 112 Where false data, documents or samples are provided or other fraudulent acts are committed in applying for vaccine clinical trials and registration, the case shall be handled according to Article 81 of the Vaccine Administration Law.

Article 113 Where, in the drug registration process, drug non-clinical safety evaluation and research institutes and drug clinical trial organizations fail to comply with GLP or GCP etc., the case shall be handled according to Article 126 of the Drug Administration Law.

Article 114 Where a drug clinical trial is conducted without approval, the case shall be handled in accordance with Article 125 of the Drug Administration Law; where a bioequivalence trial is conducted without filing, the case shall be handled in accordance with Article 127 of the Drug Administration Law.

Article 115 Where clinical trial sponsors fail to promptly adjust the clinical trial protocols, suspend or terminate the clinical trials or report to the NMPA when safety issues or other risks are discovered during drug clinical trials, the case shall be handled according to Article 127 of the Drug Administration Law.

Article 116 In any of the following circumstances in violation of Articles 28 and 33 of these Provisions, the sponsor shall be ordered to make corrections; where corrections are not made within the specified timeline, the sponsor shall be imposed a fine of not less than RMB 10,000 but not more than RMB 30,000.

(1) Fail to register on the drug clinical trial registry and information disclosure platform as required before conducting drug clinical trials;

(2) Fail to submit the DSUR as required;

(3) Fail to register the clinical trial results and other information after completion of clinical trials.

Article 117 Where a drug testing institution undertaking testing for drug registration issues false testing reports, the case shall be handled according to Article 138 of the Drug Administration Law.

Article 118 Where approval is given to drug clinical trials that do not meet the requirements, or Drug Approval Licenses are issued to drugs that do not meet the requirements, the case shall be handled according to Article 147 of the Drug Administration Law.

Article 119 Where drug regulatory departments and their staff violate laws and regulations in drug registration administration, the case shall be handled according to relevant laws and regulations.