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Safety reporting to Chinese FDA



  • ANON
    25/02/2018 21:10
    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
    18/03/2018 17:49
    Dear Anon This area is indeed not very well defined, but some guidance is already available. http://www.cirs-reach.com/news-and-articles/cfda-issued-the-administrative-measures-of-foods-for-special-medical-purpose-(fsmp)-registration-(trial)-(draft).html We strongly suggest that your local CRO in China obtains written confirmation that no CFDA approval is required (as this may also depend on the type of study, type of food/health food). In addition, the CRO should also liaise with organisations "below" the CFDA and obtain written confirmation whether a registration for a food trial is required by them or not. - National Institute for Food and Drug Control (NIFDC) - Province Institute for Food and Drug Control (PIFDC) Please be aware that you may still require an import licence from the CFDA (SEE http://eng.sfda.gov.cn/WS03/CL0771/98122.html) . We would like to apologise for the delay in replying.
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