Takehome:
- “Guidance for Health Food Registration Application” has been released which mainly specifies the requirements of health food application registration dossiers.
On Dec. 23, 2016, China CFDA released the 2016 version of “Guidance for Health Food Registration Application”, which gives includes detailed explanations on health food registration dossier requirements under the new health food regulatory system as specified in “Administrative Measures for Registration and Filing of Health Foods”.
This Guidance specifies heath food registration procedure for both domestic and imported health food, which is applicable to health foods which use new raw materials, and health foods imported for the first time (excluding nutrient supplements).
The requirements for health food registration application dossiers are interpreted in this Guidance, including applicant qualification certificates, product R&D report, product formula, production technology materials, evaluation materials for safety and health functions, packaging materials and labels, samples of minimum sale package, etc.
This Guidance also covers the requirements for:
- Change of registration
- Registration renewal
- Technical transfer
- The application requirements for the products using extracts as the raw materials
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