Recently, the State Administration for Market Regulation revised and issued the "Administrative Measures for the Registration of Food Formulae for Special Medical Purposes" (hereinafter referred to as the "Measures"), which will come into force on January 1, 2024.

Formula food for special medical purposes (hereinafter referred to as special medical food) refers to formula food specially processed and formulated to meet the special needs of nutrients or diet of people with dietary restrictions, digestive and absorption disorders, metabolic disorders or specific diseases. Special medical food plays an important role in nutrition support for patients' disease treatment, rehabilitation and body function maintenance, and its quality and safety are related to the health and life safety of special people.

The "Measures" implement the "four strictest" requirements for food safety, combined with industry development and registration management practices, further strict product registration conditions, requirements, procedures, to ensure product quality and safety and clinical effects, emphasizing the clinical needs of the oriented, encourage enterprises to develop clinical products urgently needed, and continue to expand the accessibility of special groups.

The Measures, consisting of 7 chapters and 64 articles, provide provisions for overseas manufacturers who intend to produce and sell special medical food in China and export special medical food to China in terms of application conditions, registration procedures, clinical trials, labels and instructions, supervision and management, and legal liabilities. The main contents include:

First, strict product registration and detailed management requirements. Further emphasize the applicant's qualifications, abilities, legal responsibilities and obligations; Clarify 7 cases of unregistered products; Refine on-site verification requirements, and carry out extended verification of raw materials when necessary; Add the item of "Other technical requirements for products" to the registration certificate to further ensure the safety and effectiveness of product quality.

Secondly, encourage research and development innovation to meet clinical needs. Establish a priority review and approval procedure, implement priority review for products such as rare disease categories, clinically urgent and not yet approved new categories, reduce the review time limit from a maximum of 90 working days to 30 working days, prioritize on-site verification and sampling inspection, and encourage enterprises to develop new products to meet clinical needs.

Third, standardize the label identification and safeguard the rights and interests of consumers. It is emphasized that the label of special medical food should be true, accurate, clear and obvious, and meet the requirements of regulations and standards; Strictly label the content that the main display page should be marked, so as to facilitate consumer identification; It is clear that the product label shall not make functional claims on the nutrients and other ingredients in the product to prevent misleading consumers.

Fourth, optimize the registration process and improve the registration efficiency. Optimize the on-site verification process of registration, give enterprises 30 working days to feedback whether to accept on-site verification, and specify the specific verification time, taking into account the verification preparation and work time; Reduce the time limit for on-site verification of clinical trials by 10 working days to improve the efficiency of product registration; Clarify the legal effect of e-certificates and facilitate the service of enterprises.

Fifth, strict supervision and management, strengthen legal responsibility. Applicants suspected of concealing the true situation or providing false information during the registration process shall be expressly prohibited from withdrawing their registration applications and shall be dealt with according to law. To obtain registration certificates by fraud and bribery, as well as forgery, alteration, resale, rental, lending, transfer of registration certificates and other illegal acts, increase penalties. Whoever is suspected of committing a crime shall be transferred to a public security organ and investigated for criminal responsibility.

See the original text from SAMR: https://www.samr.gov.cn/xw/zj/art/2023/art_5fe72814a5ab401aae42c0eaa3b029d9.html