On November 28, 2023, the State Administration for Market Regulation of China issued the "Administrative Measures for the Registration of Food for Special Medical Purposes" (hereinafter referred to as the "Measures"), which will be implemented from January 1, 2024. The previous version was published on March 7, 2016, and has been simultaneously abolished.
The revised "Measures" consist of 7 chapters and 64 articles, covering application requirements, registration procedures, clinical trials, labeling and instructions, supervision and management, legal responsibilities, and other aspects.
The main contents include:
1. Strict product registration and detailed management requirements. The Measures further emphasize the conditions, capabilities, legal responsibilities, and obligations that applicants should possess. They specify seven situations in which products cannot be registered. The Measures also provide detailed requirements for on-site inspections and may conduct extended inspections of raw materials when necessary. The "Other Technical Requirements" item is added to the registration certificate to further ensure the quality, safety, and effectiveness of the products.
2. Encouraging research and development innovation to meet clinical needs. The Measures establish a priority review and approval procedure, which prioritizes the review of products belonging to categories such as rare diseases or clinical emergencies that have not yet been approved. The review time is reduced from a maximum of 90 working days to 30 working days. On-site inspections and sampling inspections are given priority. The Measures encourage enterprises to develop new products to meet clinical needs.
3. Standardizing labeling and ensuring consumer rights. The Measures emphasize that labels of food for special medical purposes should be truthful, accurate, clear, and prominent, in accordance with regulatory standards. They strictly define the content that should be displayed on the main display area of the label to facilitate consumer identification. The Measures also specify that product labels should not make functional claims about nutrients and other components to prevent misleading consumers.
4. Streamlining the registration process and improving efficiency. The Measures optimize the on-site inspection process for registration, allowing enterprises 30 working days to provide feedback on whether they accept on-site inspections. The specific inspection time is clearly defined, taking into account inspection preparation and work efficiency. The time limit for on-site inspections during clinical trials is reduced by 10 working days, aiming to improve the efficiency of product registration. The legal effect of electronic certificates is clarified to facilitate convenience for enterprises.
Other highlights:
To apply for a registration change, it is necessary to submit a product change justification report, which clarifies that the food ingredients, food additive varieties, ingredient list order, and nutrient composition table remain unchanged. If the usage amount fluctuates or adjusts within a certain reasonable range, no change registration is required.
To apply for a registration continuation, it is necessary to submit materials such as information on the enterprise's research and development capabilities, production capabilities, and testing capabilities, as well as the tracking evaluation of product safety, nutritional adequacy, and special medical clinical effects.
Official source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_9b1a9daffc084d819bb4d7a31d909452.html
