Takehome:
The requirements on health food registration technical review are released including technical review on safety, health functions and quality controllability, as well as the situations that the registration application will be disapproved under the new regulation.
On Jun. 8, 2016, China Food and Drug Administration (CFDA) preannounced “Detailed Rules for Health Food Registration Technical Review” as well as the requirements on health food registration dossiers. The period for public consultation is until Jun. 17, 2016.
This rule is applicable to the technical review for health food registration, technical transfer, change of registration, and registration renewal.
Technical review for health food registration mainly focuses on three aspects of safety, health functions, and quality controllability, including the reviews on:
- Product safety
- Health functions
- Production process
- Product technical requirements
- Labels and users’ directions
Field inspection
The decision on whether field inspection is required shall be made based on the evaluation result of application materials. The product R&D report, formula, and production technique in the application materials will be examined as well as the rationality and feasibility of product process design.
Reexamination
The determination method mentioned in the application materials will be reexamined to verify its scientific basis, reproducibility and applicability, and the product quality controllability will be reexamined as well.
The registration application will not be approved if:
- The product traceability materials are not provided as required;
- Product safety, health functions or quality controllability is not compliant with relevant requirements;
- The test method for efficacy components or iconic components is not verified;
- The study on product stability is not complete or scientific;
- Supplementary materials are not provided or corrected within the time limit;
- The product actually requires filing;
- The product for supplementing vitamins and minerals does not conform to raw material approval standard specified in “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”;
- Field inspection or reexamination result is not concluded as compliant.
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