On May 15, 2024, in accordance with the Administrative Measures for Foods for Special Medical Purposes Registration (Announcement No. 85) issued by the State Administration for Market Regulation (SAMR), the Center for Food Evaluation (CFE) has reviewed the registration applications for FSMP seeking priority review and approval, and is now making public FSMP proposed for this procedure. The public notice period is 5 working days.

In 2023, 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) were officially approved as new food nutrition enhancers in China, marking a regulatory milestone regarding human milk oligosaccharides (HMOs), a globally recognized category of essential nutrients. Since then, several other HMOs continue to progress along the compliance pathway: on May 10, 2024, the Center for Food Safety Assessment (CFSA) issued the draft and reopened the period for public consultation for 2’-FL and LNnT.

To standardize the clinical trial process of foods for special medical purposes (FSMP), the State Administration for Market Regulation (SAMR) recently revised and issued the Quality Management Specifications for Clinical Trials of Foods for Special Medical Purposes (the Specification), which aims to ensure the scientific integrity, authenticity, and reliability of data and results, while safeguarding the safety and rights of trial subjects and consumers.

In order to standardize the procedure for the priority review and approval of registration of food for special medical purpose (FSMP), in accordance with the Administrative Measures for the Registration of Foods for Special Medical Purpose, the State Administration for Market Regulation (SAMR) has drafted the Procedures for Priority Review and Approval of Registration of Foods For Special Medical Purpose for public feedback. Comments are welcomed before May 30, 2024.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper inspection capabilities for producing its products, and conduct batch-by-batch inspections of manufactured products according to relevant laws, regulations, and national food safety standards for infant formula milk powder.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper production capabilities compatible with the production of its products, comply with good manufacturing practices for powdered infant formula foods, and implement a Hazard Analysis and Critical Control Point (HACCP) system. When applying for infant formula milk powder registration, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including “8) Materials on R&D, production, and inspection capabilities”. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper R&D capabilities aligned with its products. When applying for registration of infant formula milk powder products, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including 8) Materials on R&D, production, and inspection capabilities. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

On April 3, 2024, in accordance with the Measures for the Registration of Food for Special Medical Purpose (Announcement No. 85) issued by the State Administration for Market Regulation (SAMR), the Center for Food Evaluation (CFE) has reviewed the registration applications for FSMP seeking priority review and approval, and is now making public the proposed FSMP for the priority process. The public notice period will be in effect for 5 working days.

According to the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 181. 17 FSMPs have been approved in the first quarter of 2024, including 16 domestic products and 1 imported. These include 3 domestic nutritionally complete products, 8 domestic nutritionally incomplete products, 5 domestic infant formula for special medical purposes, and 1 imported infant formula for special medical purposes.

Detailed information on 181 registered FSMP products