CDE issues the Regulationon (Trial) on the Registration of Drug Clinical Trials and The Administration of Information Disclosure.

In accordance with the "State Drug Administration's Announcement on the Implementation of <> Related Matters (No46 of 2020)," in order to promote the drafting and formulation of relevant supporting normative documents and technical guidelines, under the deployment of the State Drug Administration, the Drug Review Center organization has formulated the "Regulations on the Registration and Information Disclosure of Drug Clinical Trials (Trial)" (see annex), which is approved by the State Drug Administration and is now issued from July 1, 2020hereby hereby noticethe Drug Review Center of theState Drug AdministrationJuly 1, 2020
Article 1 In order to implement the Drug Administration Law, adhere to the risk management of drug clinical trials, full control, social co-treatment, do a good job in the disclosure of drug clinical trials, strengthen the supervision and management of drug clinical trials, protect the legitimate rights and interests of subjects, follow ethical principles and refer to international practices, and formulate this management regulation in accordance with the Measures for the Administration of Drug RegistrationArticle 2 The Drug Review Center of the State Drug Administration (hereinafter referred to as the Drug Review Center) shall establish, maintain and update the "Drug Clinical Trial Registration and Information Disclosure Platform" (hereinafter referred to as the Registration Platform) in accordance with the overall requirements of the State Drug Administration, and formulate and update the guidelines for the use and filling out the registration platformArticle 3 The applicant shall bear the principal responsibility for the authenticity and completeness of the registration information for drug clinical trialsThe applicant may register the drug clinical trial information by authorized or entrusted, and the registration platform shall not be liable for the transfer, authorization or entrustment of the applicant's drug clinical trial approval documents and registrationArticle 4 The registration and information disclosure records of drug clinical trials will be related to communication, technical review, supervision and inspection in the process of drug clinical trialsArticle 5 Clinical trial information published on the registration platform, free of charge by the public to query and retrieveArticle 6 If any of the following circumstances are included, the applicant shall register the clinical trial information on the registration platform in accordance with this management specification before conducting a clinical trial of the drug, and continuously update it in accordance with the progress of the clinical trial(1) has obtained the drug clinical trial license document of the State Drug Administration and conducted clinical trials in China;(2) has completed the clinical trial of the biological equivalent test of chemical drugs and obtained the record number for the clinical trial;(3) the phase IV clinical trial and post-marketing research conducted in accordance with the drug registration certificate or the notification requirementissue issued by the drug regulatory department; and(4) other cases registered according to regulatory requirements Article 7 If the applicant has obtained the drug clinical trial license document and can only register the drug clinical trial information within the validity period, the chemical drug biological equivalence test managed in accordance with the filing needs to be completed for filing and obtained the filing number before registration can be obtained, and if the other circumstances need to be registered, the applicant shall provide the relevant supporting documents and shall be approved and the relevant requirements shall be approved for registration If no subject signs an informed consent form within three years from the date of approval of the application for a clinical trial of a drug, the license of the drug clinical trial shall be invalid and shall not be registered Article 8 The applicant registers and updates the information of the drug clinical trial through the name and password of the account Article 9 A clinical trial corresponds to a clinical trial program number and can only register one record The registration information will automatically generate a unique drug clinical trial registration number (CTR) after it is first submitted Article 10 The registration information for drug clinical trials is divided into first-required and first-time optional, renewable and non-renewable, public and non-public items according to their content and nature The contents of the registration platform of Article 11 include licensing documents and related information approved for drug clinical trials, information on experimental drugs, information of applicants, information on clinical trial programs, information of principal researchers, information of participating institutions, information of ethics committees, information on test status, information on test results, registration contact information, relevant attachments, etc Article 12 Applicants shall register and update the information on drug clinical trials in strict accordance with the instructions for the use of the registration platform and the requirements of filling out the guidelines Article 13 The applicant shall carry out quality control on the accuracy of the registration information, and once the items are updated, the applicant may not modify it himself Article 14 The applicant shall complete all the first required items and complete the first submission within the validity period of the drug clinical trial license document Initial registration, submission and publicity should be completed prior to the recruitment of the subjects Article 15 After the update of the information on drug clinical trials, the applicant shall submit the updated information within twenty working days For those who voluntarily suspend or terminate a clinical trial for safety reasons, the applicant shall update the test status information within ten working days, and if the clinical trial is ordered to be suspended or terminated, the drug trial center shall update the test status and make it public immediately After the completion of the clinical trial, the applicant shall register the clinical trial results information on the registration platform within twelve months after the completion date of the clinical trial, and for registered clinical trials that support the listing application, it is recommended that the registration of clinical trial results information be completed prior to the listing application, whichever occurred earlier Clinical trial results information should contain at a minimum the contents of the clinical study report outlineas set out in the International Coordinating Committee on Human Drug Registration Technology (ICH) E3: The Structure and Content of Clinical Research Reports Article 16 The Drug Review Center conducts a normative and logical examination of the information of the drug clinical trial registered by the applicant This normative and logical review does not imply that the Drug Review Center and the applicant have reached some kind of commitment, approval, or contract with the applicant regarding the scientific rationality of the drug clinical trial program Article 17 The Drug Trial Center shall review the information on the drug clinical trial registered by the applicant in accordance with the requirements of the existing laws and regulations, the drug clinical trial license documents, the registration platform to fill out the guidelines, and the communication and exchange of the meeting minutes Article 18 The information on clinical trials of drugs registered by the applicant shall be made public if it meets the requirements of the drug clinical trial licensing information and the completion of the guidelines The main information published includes basic information on experimental drugs, applicant information, basic information of clinical trial program, information of principal researchers, information of participating institutions, information of ethics committees, information on test status, except for information and annexes that are not publicized only for supervision and management purposes article 19 The information on clinical trials of drugs registered by the applicant shall, if it does not meet the requirements of the drug clinical trial license information or fills out the guidelines, return to the applicant for amendment, and after all the amendments, shall be given public notice if the requirements are met by examination article 20 of the , for the registration of clinical trial sandaries of drugs that do not meet the provisions of this management specification, the applicant shall not be returned to the applicant, and the reasons for the applicant's non-registration shall be informed Article 21 If the applicant is required to withdraw the published registration information for clinical trials of drugs, he or she shall state the reasons for the withdrawal of registration, and after examination and compliance with the requirements, he shall agree to withdraw the registration Article 22 For the registration of a clinical trial of a drug voluntarily withdrawn by an applicant, if the applicant can provide relevant supporting the registration with relevant supporting documents, he may re-register and, after examination and compliance with the requirements, be given public ity Article 23 Except in exceptional circumstances, the time limit for the examination of the registration information for drug clinical trials shall not exceed fifteen working days from the date on which the applicant submits the information Article 24 The applicant may consult on the relevant issues related to the registration of drug clinical trials and the publicity of information in accordance with the communication time and method prescribed by the Drug Review Center, and the relevant information may be queried on the official website of the Drug Review Center Article 25 This regulation shall come into effect on July 1, 2020.