China Revises Administrative Measures for FSMP Registration
Dec 05, 2023
Sadie Shen
SAMR establishes priority review and approval procedures for foods for special medical purpose (FSMP) for rare diseases as well as unapproved new FSMP types that are clinically urgent. The technical evaluation period is shortened to 30 working days from 60 working days.
The duration for conducting on-site inspections on clinical trials has been shortened from 40 working days to 30 working days.
Electronic certificates hold the same legal validity as their paper counterparts.
No functional claims should be made regarding the nutrients and other ingredients in the product.
On December 3, 2023, State Administration for Market Regulation (SAMR) unveiled the updated Administrative Measures for Registration of Foods for Special Medical Purpose, replacing the 2016 version. Major revisions include priority review and approval procedures, situations not approved for registration, labels, penalties, and measures to optimize the registration procedure. The new version will come into force on January 1, 2024.
Recommended reading:
Unveiling Market Prospects and Import Guidelines for Food for Special Medical Purposes in China
Major Revisions
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