Safety reporting to Chinese FDA
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For a study without a drug (nutritional product) the local CRO in China confirmed that the study/protocol should not to be registered with the CFDA, but the SAEs are to be reported to the CFDA consistent with the process and timelines as used for pharma studies. This seems confusing. I could not find useful information on the website of the CFDA. Has anyone experience with the PV process in China.
RQA GPvP Committee