CFDA Revised the Administrative Measure on Health Food Registration and Filing

Article number

Main revised contents

Article 7, paragraph 2

Add “the registration applicant shall proactively disclosure the scientific literatures and experimental basis that related to the product function”.

Article 16, paragraph 1

Change "the review board should organize review experts to evaluate the application materials "into” the review board should organize to evaluate the application materials". The "review experts" is removed.

Article 32

Add “if the applicant does not apply for renewal 6 months before the expiration date, he can still apply for registration renewal before the expiration date. However, when the renewal application is accepted, the enterprise shall stop production when the expiration date ended. He can put back on production when the renewal application is approved”.

Previously, if the applicant does not apply for renewal 6 months before the expiration date, the registration certificate cannot be renewed. This change gives a relief approach to such applicant.

Article 38

The main change is “the review board organize to evaluate the registration alteration or registration renewal application materials and make the final decision of approval or disapproval”.

This change means the final approval decision of registration alteration or registration renewal application is planned to be made by the review board, not CFDA any longer.

Article 55

I. The claim of “本品不能代替藥物的疾病預防、治療作用” (this product cannot replace the disease prevention and treatment effect of drug) shall be indicated on the label and specification;

II. If the product has not been evaluated by human consumption, the claim of “本品僅經動物實驗評價” (this product is only evaluated by animal tests) shall be added into the health function claims;

III. If the product has been evaluated by human consumption, the claim of “本品經人群食用評價” (this product is evaluated by human consumption) shall be added into the health function claims.

Article 75

This is a new article. The contents are as follows: “The electronic certificate of health food registration made by the FDA department has the same legal effect as the printed health food registration certificate.”