On Feb. 27, 2016, China Food and Drug Administration (CFDA) released the final version of “Administrative Measures for Health Food Registration and Filing”, which will be formally implemented from Jul. 1, 2016. The “Measures on the Administration of Health Food Registration (Interim)” which has been implemented for more than 10 years (since 2005) will be abolished simultaneously.
China Health Food Premarket Guideline
Administrative Measures for Registration and Filing of Health Food
One formula for one product:
A single enterprise shall not apply for registration or filing of a single formula using different names, or use the same name for registration or filing health foods with different formulas.
Qualification of applicants:
Imported health food registration and filing applicants shall be overseas listed health food manufacturers.
Optimization of health food registration procedure:
The field inspection and reexamination for health food registration have been included into the technical review procedure rather than being carried out independently as before. The duration for field inspection and reexamination for health food imported for the first time shall be subject to the actual condition of overseas manufacturers.
Procedure for technical review includes:
- Review of application materials
- Field inspection
- Sampling inspection
- Reexamination
Requirements for health food technical transfer:
The transferee of health food technical transfer shall reapply for product registration under the guidance of transferor with the same requirements for application materials, but the review procedure will be simplified accordingly.
Influence on approved health foods:
After the new regulation is formally put into practice health foods which have already been approved will be scheduled to change their approval certificate batch by batch to ensure the consistency of technical review standards for all products.
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