Takehome:
- CFDA announced the formal implementation of the new health food registration and filing system with relevant supplementary requirements released.
On Jun. 30, 2016, CFDA announced the formal implementation of “Administrative Measures for Registration and Filing of Health Foods” from Jul. 1, 2016 without any grace period, which opens up a new chapter for health food regulatory management system in China. Relevant supplementary requirements have also been released at the meantime.
From Jul. 1, 2016, the application for health food registration will be accepted only by CFDA rather than any provincial food and drug administration departments.
As nutrient supplements will require filing rather than registration after the implementation of the new regulation, no reexamination and field inspection obligation is required under the filing procedure. If the reexamination and field inspection for registration were finished before Jul. 1, 2016, the applicant may also submit relevant reexamination and field inspection reports for evaluation to obtain a filing number rather than a registration number.
In case a review opinion is given which requires dossier supplementation, the applicant should submit relevant supplementary materials strictly according to review opinion requirements. In case of any failure, the registration application procedure should be restarted.
A half-year grace period has been granted for the application for health food registration certificate renewal. The registrant should make application for health food registration renewal 6 months prior to the expiry date of the registration certificate from Jan. 1, 2017. The permitted period was 3 months before the implementation of the new regulation.