Release Date: 20230317

       In order to further promote the implementation of ICH E2A, E2B (R3) and regional implementation guidelines, to promote the unification of the standard of rapid reporting of safety data during drug clinical trials, and to improve the quality of data, under the deployment of the State Drug Administration (SDA), the Center for Drug Evaluation (CDE) organized the development of the "Frequently Asked Questions and Answers on Rapid Reporting of Safety Data during Drug Clinical Trials (Version 2.0)" (see annex).

       According to the "State Drug Administration Comprehensive Department on the issuance of drug technical guidelines on the issuance of the notice of the procedure" (Drug Administration General Drug Administration [2020] No. 9) requirements, by the State Drug Administration review and approval, is hereby issued, from the date of issuance shall come into force. Frequently Asked Questions on Rapid Reporting of Safety Data during Drug Clinical Trials (Version 1.0) is hereby repealed.

       Hereby notified.

       Annex: Frequently Asked Questions on Rapid Reporting of Safety Data during Drug Clinical Trials (Version 2.0)

                                                                                                                                                                        Drug Review Center of State Drug Administration

   March 17, 2023