CHINA FDA ISSUES GUIDELINES FOR THE FILING OF HEALTH FOOD

According to the “Administrative Measures for Registration and FilingManagement of Health Food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food”and the health food that is imported at the first timeincludedthe supplemented vitamin, mineral and other nutrients.

On May 2, 2017, CFDA has formulated and published the “Guideline for filing of health food (trial)”, and it has taken effect since the date of promulgation.

The filing of health food refers to such process that the health food manufactures submit the materials indicating the safety, health functions and quality control of the products to the food and drug administration department for filing, publicity and future reference in accordance with legal procedures, conditions and requirements.

This guideline mainly stipulates theapplication scope, filing subject, filing process and requirements, requirements of filing materials format of health food filing, as well as the requirements of the filing materials for domestic & imported health food. 

Application Scope

This guidelineapplies to the filing of health food stipulated in the “Administrative measures for registration and filingmanagement of health food”.

Filing Subject

This guideline provides technical guidance for the filing of health food. Domestic and imported health food enterprises shallstrictly follow thisGuideline.

Filing process

1 Obtain the login ID of filing system

2 Fill and submit the filing information of product

3 Release the filing number, file and make it public. Food Regulatory Information Express in China

The items for filing materials of domestic health food

1.      The registration form for filing of health food, and letter of commitment on legal liability of filing person responsible for the authenticity of the submitted materials

2.      The supporting document of subject registration of the filing person

3.      The product formula materials

4.      The materials of product manufacturing process

5.      Materials of evaluation on safety and healthcare function

6.      The type, name and standards of packaging materials directly contacting with health food

7.      The manuscript of product label and instruction

8.      The materials of product technical requirements

9.      The all-items inspection report issued by the inspection agency entitled with legal qualification and in conformity with the product technical requirements

10.   Related searchin gmaterials of product name

11.   The other materials indicating the safety and health function of products

The items for filing materials of imported health food

In addition to the relevant materials submitted as domestic products, the following materials shall also be submitted:

1.      The supporting documents for registrationof filing person subject

2.      The supporting documents certifyingthat thehealth food has been put intothe market for more than one year

3.      The original texts of technical regulations or standards related to the filed health food of producing country (region) or international organizations

4.      The actual samples of packaging, label and specification of product sold in the producing country (region)

5.      Where thefiling affairs are handled by the permanent representative organization to China of the overseas filing person, the scanned copyof “Registration Certificate of the Permanent Representative Organization to China of Foreign Enterprises” shall be submitted

6.      The original supporting documents, and power of attorney (agreement), etc. issued by overseas organizations

7.       The supporting documents of production and sales, quality management system or GMP, and manufacturing consignment agreement