In order to guide the drug clinical trial sponsors to standardize the work related to protocol changes during clinical trials, under the deployment of the State Drug Administration, the Drug Review Center organized the development of the "Drug Clinical Trial Program Changes Technical Guidelines (for Trial Implementation)" (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 comprehensive drug management [2020] No. 9) requirements, by the State Drug Administration review and approval, is hereby issued, effective from the date of issuance.

Notice is hereby given.

Annex: Technical guidelines for protocol changes during drug clinical trials (for trial implementation)

                                                                                                              June 23, 2022

Center for Drug Review, State Drug Administration