The draft Regulation is a revised version based on a previous version which was published in 2016, it applies to all Food for Special Medical Purposes (FSMPs). This regulation is revised based on the previous version published in 2016 and is applicable to all of the FSMP product registrations in China.
Comparing the previous version, there are some highlight points to consider, such as the product registration onsite audit can be extended to raw materials suppliers, for some products such as amino acid metabolism disorder formula can go through accelerated registration pathway, product specifications shall also be included in registration dossier and reflected in registration certificates, etc.
For FSMP relevant companies will need to prepare in this time window for both new registration and registration amendments and renewals.
The deadline for comment is 18 Nov.
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