China will implement a dual health food administrative system with separate requirements for health food registration and health food filing from Oct. 1, 2015. The specific dossier requirements for the two systems have been newly clarified by the government in Administrative Measures for Registration and Filing of Health Foods (Draft). The major differences in dossier requirements between the two systems are summarized as below:
Dossier Requirements for Health Food Registration and Filing System | |
Health food registration system | Health food filing system |
Application form of health food registration | Application form for health food filing |
Documentation verifying that the generic name of the health foods to be registered is not the same as the names of any registered drugs | Not required |
Product R&D materials | Not required |
Product formula materials | Same requirements |
Product technology materials | Same requirements |
Product safety and health function evaluation materials. Specific testing method for the reexamination of health food safety and health functions | Full item testing report conducted on three batches of products issued by a health food inspection institute is required. Reexamination is no longer required. |
Product technical requirements | Same requirements |
Product labels and users’ directions | Same requirements |
A comprehensive report of products’ safety, efficacy and quality control and its related scientific basis. | Not required |
Three minimum unopened sales package samples within the warranty period; | Not required |
Qualification certification of the applicant issued by the competent authority of the producing country (district) proving the applicant is the legal owner of listed products, and relevant valid period; | Same requirements |
The documents granted by relevant institutions in the producing country (district), proving the conformity of the manufacturer to relevant local production quality standards; | Same requirements |
Foreign manufactures which are represented by a permanent representative office in China should provide the Registration Certificate for Permanent Chinese Representative Agency of Foreign Companies and its copies; | Same requirements |
The documents issued by the competent authority of the producing country (district) proving that the products have been sold for more than one year; | Same requirements |
Analytic report of overseas sales and consumer’s feedback on the products; | Same requirements |
Product standard of the producing country (district) or international organizations; | Same requirements |
The samples of package, label and users’ directions of the products used in producing country (district) | Same requirements |
Three batches of products on sale or the samples that need special treatment due to inspection, the quantity of which should be three times of that used for inspection. | Not required |
Major differences:
1. For the filing system, there is no need to provide three unopened minimum sales package samples as there are no testing items during the technical review.
2. Reexamination is not required under the health food filing system.
3. Full testing report of three batches of products is still required for health food filing, the requirements of which are almost the same as those for the registration system, including product toxicology test report, function test report, human trial test report, functional ingredients or iconic composition test report, hygiene test report, stability test report, bacteria virulence test report, and stimulant and illicit drug testing.
For nutrient supplements, the testing items have been simplified to only include hygiene test, stability test, and effective ingredients or iconic composition test.
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