Takehome:
- CFDA has been accepting health food filing application since May 1, 2017.
- The finalized health food filing guidance, as well as auxiliary material directory for health food filing and major production techniques have been released.
On May 2, 2017, China CFDA finalized the “Health Food Filing Guidance” (see draft version from here), as well as auxiliary material directory for health food filing and major production techniques. CFDA has been accepting health food filing application since May 1, 2017. As the first batch of health food raw materials have already been released (see CL news report on Jan. 16, 2017), the regulatory system regarding health food filing has been basically established.
This health food filing guidance mainly specifies the filing procedures, dossier requirements, labeling requirements, etc. for both domestic and imported health food.
In the auxiliary material directory, solid preparations and liquid preparations of the same material are regulated with different requirements. The maximum dosage of solid preparations is specified as 20g/day, while liquid preparations refer to oral liquid and drops with maximum dosage less than 30ml/day. Liquid preparations dosage above 30ml/day will be regulated as beverages.
In the guidance for major production techniques, it specifies the production techniques of each dosage form of nutrient supplements (vitamins and minerals), including tablets, soft capsule, hard capsule, oral liquid, granule, as well as the materials used in premixing, imbedding, microencapsulation, etc.
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