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Question: Is it necessary to submit SUSAR to the Drug Administration and Research Center in accordance with China's GCP for non intervention research after listing
Answer: Non intervention research on products that have been listed for non registration purposes is not mandatory to comply with China GCP1. So there is no mandatory requirement to submit SUSAR to the Drug Evaluation Center (CDE) or Research Center. However, it is necessary to follow the individual case reporting requirements of the holder for post market products and report adverse drug reactions (ADRs) through the holder's adverse drug reaction direct reporting system. At the same time, the scope of clinical trials that require reporting SUSAR to CDE has been listed in "Frequently Asked Questions and Answers 1.0 for Rapid Reporting of Safety Data during Drug Clinical Trials". Reference documents: 1) Good Clinical Practice for Drug Trials (State Administration of Drugs, National Health Commission, 2020 No. 57) 2) Good Clinical Practice for Drug Vigilance (State Administration of Drugs, 2021 No. 65)