On 23 December 2016, China Food and Drug Administration (CFDA) published a formal regulation called Health Food Registration Application Service Guideline (the Regulation) which updated the draft published on 8 June 2016. The new regulation has registration requirements including for new products, altered products, renewing product registration belonging to vitamin, mineral or other nutriment supplements category.
What is Health Food Registration (Big Blue Hat)?
CFDA undertake an expert appraisal process and conduct a technical evaluation of the application dossier to assess the safety, function, quality of the product, and decide whether to approve the registration.
What is Health Food Filing (Small Hat)?
CFDA or provincial FDA assess the safety, function, quality of the product on site, and then archive the application dossier for future reference.
What is the difference between health food registration and filing in accordance with the new Administrative Measures?
I. Domestic health food of which the food raw materials are out of the scope of Health Food Raw Material Directory
II. Imported health food (excluded nutrition supplement )
I.Domestic health food of which the food raw materials meet the requirements in Health Food Raw Material Directory.
II. Imported nutrition supplement of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Material Directory.
I.The registration applicant of domestic health food could be the legal person or other organization registered in China.
II. The registration applicant of Imported health food should be the manufacturer.
|The filing applicant shall be the manufacturer.|
|Authority||CFDA||CFDA for imported nutrition supplement. And FDA for domestichealth food.|
|Format of the registration No. and filing No.||
I. Format of the domestic registration No. is “国食健注G+4位年代号+4位顺序号”
II. Format of the imported registration No. is “国食健注J+4位年代号+4位顺序号”
I. Format of the domestic filing No. is “食健备G+4位年代号+2位省级行政区域代码+6位顺序编号”
II. Format of the imported filing No. is “食健备J+4位年代号+00+6位顺序编号”
|Validity period of the certificate||5 years. And the applicant of health food registration should apply for certificate extension at 6 months before the expiry date.||Permanent|
|Application procedure||CFDA technical evaluation that is mandatory for registration, on-site inspection and re-test which may be required for registration are exempted for filing.|
|Application||Compared with the requirements of registration, R&D report, assessment materials regarding product safety and function or samples are not necessary to be provided when filing.|
|Cost||Compared with registration cost, the re-test cost (about 20,000 RMB) could be saved for filing.|
|Duration||Compared with registration duration, the technical evaluation (in 60 workdays), CFDA approval (in 25 workdays) on-site inspection if necessary for registration (in 30 workdays), re-test if necessary for registration (in 60 workdays) could be saved for filing.|
What do health food registration and filing have in common according to the new Administrative Measures?
|Applicant’s qualification||The applicants of imported health food registration and filing both shall be the manufacturers.|
|Authority||The authority of imported health food registration and filing both are CFDA.|
|Application||Except the exempted application for filling, other requirements of the submitted application required are the same when registration and filing.|
|Tests||Active ingredients test, hygiene test and stability test are necessary for both registration and filing.|
|Official administrative cost||No need for both registration and filing.|
|Agent for applying||Oversea manufacturer shall make the Chinese office or appoint a Chinese agent to deal with registration or filing.|