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Food Supplement Registration Process in China

Regulatory Authority:

National Medical Product Administration

Regulatory Website:

https://english.nmpa.gov.cn/

Registration Timeline:

1-3 Months

License Validity:

5 Years

Regulation:

Food items that provide vitamins and/or minerals or have particular health benefits are typically referred to as “healthy food” in China. Health food is intended to regulate bodily functions and is appropriate forparticular populations. Nevertheless, it does not have any acute, subacute, or long-term negative effects on a person’s health and is not utilized to treat illness.

As per the People’s Republic of China’s Food Safety Law (2015 edition), businesses that intend to sell health food in China must apply for and be granted a filing or registration certificate for health food. The State Administration for Market Regulation (SAMR, formerly CFDA) is the organization with which domestic health foods produced in China must register, while the Provincial Administration for Market Regulation is where the filing has to be made. Imported health foods made in foreign manufacturers must apply for both registration and filing with SAMR. In the interim, foreign businesses must designate a Chinese agent or maintain a permanent Chinese representative office to handle registration, filing, and the acquisition of these certifications.

The factory holding the production certificate is the one who must file an application for home health food. Stated differently, the domestic applicant is not able to entrust production.

 An overseas manufacturer, which includes both legal entities and other organizations, may be the filing application for imported health food. Stated differently, the applicant from abroad may entrust production.

In accordance with the DRAP Act of 2012, the Division of Health & OTC is in charge of carrying out the following duties to oversee regional producers, importers, and their goods (both human and animal).

  • Review and assessment of local importers’ and manufacturers’ applications prior to their enlistment as local importers and manufacturers.
  • Enlisting regional producers and importers.
  • Evaluation of applied products from local importers and producers prior to enlisting.
  • listing of goods with regional producers and importers.
  • Variations of local producers and importers after enlisting.
  • Post-enlistment modifications of enrolled goods from regional producers and importers
  • Evaluation of applications for local contract manufacturers to perform contract manufacturing
  • Pre-enrollment assessments of goods submitted for contract production
  • Products enlisted for contract manufacture.

Documents:

  • Application for health food filing; Letter of assurance on the validity of the materials; Copies of the applicant’s legally registered certificates;
  • ingredients used in product formulation (excipients and APIs);
  • materials used in the manufacture process of products;
  • the results of the stability test and an explanation of how the excipients and active components are used;
  • details about the packing components that come into direct contact with the goods;
  • product label and package insert samples; technical specifications for the product;
  • accordance to the technical specifications of the product;
  • Additional materials attest to the health and safety of the product.