Difference Between Health Food Registration (Big Blue Hat) and Filing (Small Hat)

1 March, 2016 China Food and Drug Administration (CFDA) published the formal “Administrative Measures on Health Food Registration and Filing”(Hereinafter called “new Administrative Measures”) which will replace the “Administrative Measure on Health Food Registration (Trial) (Order No.19)”, meanwhile, come into force on 1 July, 2016.

 Once the new Administrative Measures implemented, there will be two kinds of policy (registration and filing) for health food produced or marketed in China.

 What is Health Food Registration?

CFDA organize the expert appraisal conference and conduct the technical evaluation for submitted dossier pertaining to the safety, function, quality and so on of the health food, and finally decide whether to approve the registration.

 What is Health Food Filing?

CFDA or provincial FDA check the submitted dossier pertaining to the safety, function, quality and so on of the health food on site, and then archive the dossier for future reference.

 What is the difference between health food registration and filing in accordance with the new Administrative Measures?

Items

Registration

Filing

Applicable scope

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.

Applicant's qualification

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.

Dossier

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.

Dossier

Except the exempted dossier for filling, other requirements of the submitted dossier 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.