Takehome:
- Transitional measures for health food registration and filing have been released and will help regulate the sector until finalized health food regulations are implemented.
On Dec. 30, 2016, China CFDA released transitional measures for health food registration and filing approval to regulate registration and filing applications made prior to the implementation of the “Detailed Guidance for Health Food Registration Approval (2016 Version)” (see CL news report on Nov. 18, 2016).
It is stipulated in “Administrative Measures for Registration and Filing of Health Foods” that a filing system will apply to health foods containing raw materials within the approved health food raw material directory as well as nutrient supplements. However, the corresponding positive lists of raw materials and function claims which will serve as the foundation for the filing system have not been finalized. Therefore, these products are still subject to registration under the current system. After these two positive lists are released the filing system will then apply.
Health foods subject to registration and/or registration renewal will undergo technical review according to “Detailed Guidance for Health Food Registration Approval (2016 Version)”, and the notification for supplementation of relevant application dossiers will be sent to the applicant as per the technical review result. Before Jul. 1, 2018, the applicant may still submit the supplementary dossiers within 5 months according to 2005 version of “Health Food Registration Management Approach” that has already been repealed. After that specific date, the time limit for application dossier supplementation will be shortened to 3 months.
For products subject to change of registration, technical transfer, and reissuance of approval certificate, the original procedure and requirements will remain unchanged.