SAMR prioritizes review and approval of FSMP for rare diseases
China
Sep 22, 2023
The State Administration for Market Regulation (SAMR) is currently trialing a priority review and approval process for urgent clinical needs related to foods for special medical purposes (FSMP) for rare diseases. They also propose to implement the "Management of Registration of Food Formulas for Special Medical Purposes". Relevant content has been added in the review of the measures, shortening the review timeframe for the review of the registration of formulas for special medical purposes for rare diseases from 60 working days to 30 working days and prioritizing on-site inspections and sampling inspections.
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