Chapter III Drug Marketing Registration

Section I Drug Clinical Trials

Article 20 Drug clinical trials mentioned in these Provisions refer to drug research conducted with humans to establish the safety and efficacy of drugs for the purpose of drug marketing registration.

Article 21 Drug clinical trials are classified as phase I, II, III, IV and bioequivalence trials. According to the drug characteristics and research purposes, the research includes clinical pharmacology studies, exploratory clinical trials, confirmatory clinical trials and post-marketing studies.

Article 22 Drug clinical trials shall be conducted in qualified and filed clinical trial institutions. Vaccine clinical trials shall be carried out or organized by Class III medical institutions or disease prevention and control institutions above the provincial level that meet the requirements prescribed by the NMPA and the National Health Commission.

Article 23 Having completed the CMC, pharmacological and toxicological studies supporting drug clinical trials, to file a drug clinical trial application, the applicant shall submit relevant study data as per requirements on application dossiers. The application shall be accepted when the application dossiers pass preliminary review. The CDE shall organize CMC, medical and other technical personnel to evaluate the drug clinical trial application accepted. The decision on whether to approve the drug clinical trial shall be made within 60 days upon acceptance, and the applicant shall be informed of the review and approval result via the CDE website; where no notice has been issued within the specified timeline, the application shall be deemed approved, and the applicant may carry out the drug clinical trial as per the submitted protocol.

An applicant who is approved to carry out clinical trials of drugs shall be the sponsor of drug clinical trials (hereinafter referred to as the sponsor).

Article 24 To carry out a bioequivalence trial, the applicant shall file the bioequivalence trial at the CDE website as required before carrying out relevant studies as per the filed protocol.

Article 25 Drug clinical trials shall be subject to review and approval by the ethics committee.

The management of drugs for clinical trials shall conform to the relevant requirements of the GCP.

Article 26 When the drug clinical trial application is approved, the sponsor shall formulate the corresponding drug clinical trial protocols and have them reviewed and approved by the ethics committee before carrying out the subsequent phases of clinical trial, and submit the corresponding protocols and supporting dossiers on the CDE website.

Article 27 For a drug approved for clinical trials, where an indication is to be added or the drug is to be used in combination with other drug(s), the applicant shall file a new drug clinical trial application to the CDE, and after approval shall the new drug clinical trial be conducted.

For a drug approved for marketing, where an indication is to be added and clinical trials are required, a new drug clinical trial application shall be filed.

Article 28 The sponsor shall periodically submit development safety update report (DSUR) on the CDE website. The DSUR shall be submitted annually within two months after each full year as of approval of the drug clinical trial. The CDE may require the sponsor to adjust the reporting period depending on the review.

For suspected unexpected serious adverse reactions (SUSAR) and other potential serious safety risk information occurring during the drug clinical trials, the sponsor shall promptly report to the CDE as per relevant requirements. The CDE may require the sponsor to intensify risk control actions by modifying the clinical trial protocol, the informed consent form and the investigator's brochure, etc., and when necessary suspend or terminate the clinical trials, depending on the severity of safety risks.

The specific requirements for the DSUR shall be formulated and published by the CDE.

Article 29 In case of drug clinical trial protocol changes, non-clinical/CMC changes or new findings during the drug clinical trial period, the sponsor shall, in accordance with the provisions and with reference to the relevant technical guidelines, make a comprehensive assessment on the impact on the safety of subjects.

Where, upon assessment, the sponsor considers that subject safety is not affected, the changes may be directly implemented and reported in the DSUR. Where subject safety risks may be increased, a supplementary application shall be filed. The decision on whether or not to approve a supplementary application shall be made within 60 days upon acceptance and the applicant shall be informed of the result via the CDE website; where no notice has been issued within the specified timeline, the supplementary application shall be deemed approved.

Where the sponsor changes, the post-change sponsor shall undertake responsibilities and obligations related to the drug clinical trial.

Article 30 Where safety issues or other risks are observed during drug clinical trials, the sponsor shall promptly modify the clinical trial protocol, suspend or terminate the clinical trial, and report the case to the CDE.

In any of the following circumstances, the sponsor may be required to modify the clinical trial protocol, suspend or terminate the drug clinical trial:

(1) The ethics committee fails to perform its duties;

(2) Safety of the subjects cannot be effectively ensured;

(3) The sponsor fails to submit the DSUR as required;

(4) The sponsor fails to deal with and report SUSAR in a timely manner;

(5) There is evidence indicating the investigational drug is ineffective;

(6) A quality problem occurs with drugs used in the clinical trial;

(7) A fraud has been committed during the drug clinical trial;

(8) Other circumstances where the GCP is violated.

Where extensive and unexpected serious adverse reactions occur during the drug clinical trial or there is evidence indicating the investigational drug has serious quality problems, the sponsor and the drug clinical trial institution shall immediately terminate the drug clinical trial. The drug regulatory departments may order modification of the clinical trial protocol, suspension or termination of the drug clinical trial as per their duties.

Article 31 Where suspension of a drug clinical trial has been ordered and the sponsor plans to continue the drug clinical trial, a supplementary application for resuming the drug clinical trial shall be submitted after taking rectification actions, and the drug clinical trial may be continued after the application is reviewed and approved. Where a drug clinical trial has been suspended for three years and no application has been filed and approved for resumption of the drug clinical trial, the drug clinical trial permit shall cease to be valid automatically.

Where the sponsor plans to continue a drug clinical trial after it has been terminated, a new drug clinical trial application shall be submitted.

Article 32 A drug clinical trial shall be conducted within three years after approval. Where no subject has signed any informed consent form within three years since the date when the clinical trial application was approved, the drug clinical trial permit shall cease to be valid automatically. Where the sponsor plans to continue the drug clinical trial, a new drug clinical trial application shall be submitted.

Article 33 The sponsor shall, before carrying out the drug clinical trial, submit the drug clinical trial protocol and other information on the drug clinical trial registry and information disclosure platform. During the drug clinical trial, the sponsor shall continually update the registered information and, after the drug clinical trial ends, submit results of the drug clinical trial and other related information. Information posted on the platform shall be disclosed to the public. The sponsor is responsible for the authenticity of registered information about the drug clinical trial.

Specific requirements for drug clinical trial registry and information disclosure shall be formulated and published by the CDE.