On April 23, the State Administration for Market Regulation (SAMR) of China issued the Q&A on the Registration of Foods for Special Medical Purposes Infant Formula under the New National Standard (hereinafter referred to as the “Q&A”). The purpose of the Q&A is to facilitate the re-registration process following the promulgation of the National Food Safety Standard - General Rules for Food for Special Medical Purpose Infant Formula (GB 25596—2025) (hereinafter referred to as the “New National Standard”), guide enterprises in the standardized submission of applications, and ensure a smooth market transition.

On March 27, 2025, Chinese NHC released 50 new national food safety standards, including GB 25596-2025: National Food Safety Standard – General Principles for FSMP Infant Formula. The transition period for this new standard, based on previous regulations and a comprehensive evaluation of various factors, has been set at two years. It will officially come into effect on March 16, 2027.

As of now, China has officially approved five special medical-purpose liquid formula foods designed for individuals aged 10 and above who require fat intake restriction or have digestive and absorption disorders.

Detailed information on the 230 registered Food for Special Medical purposes (FSMPs) (As of January 14, 2025)

As of January 7, 2025, the number of FSMPs approved in 2024 (with National Food Registration Numbers starting with "TY2024XXXX") has increased to 66, bringing the total number of approved FSMPs in China to 230. CIRS Group has conducted a detailed statistical summary and analysis of the 66 food for special medical purposes approved in 2024 from multiple perspectives

On December 5, 2024, CFE published eighteen frequently asked questions related to formulas for special medical purpose (FSMP), the contents covering formulas, labels and instructions for use, production process, quality and safety, clinical trail, etc.

Currently, China has officially approved 22 special medical use carbohydrate component formulas designed for people over one year who suffered from specific diseases or needs carbohydrate supplementation. 22 carbohydrate component formulas are domestically made by 20 companies, among which, DAISY FSMP and Tibet DUOXIN HEALTH were approved for 2 products each, and the other 18 companies were approved for 1 product. The largest number of approved companies is in Jiangsu Province, with a total of 7 products. The first carbohydrate component formula 泉克 was registered and approved by Tibet DUOXIN HEALTH in 2020, other carbohydrate component formulas were approved mostly in 2021, 2023 and 2024.

According to the information released by the Department of Special Food of the State Administration of Market Supervision, as of September 30, 2024, the number of domestic and foreign special medical foods that have been successfully registered in China has reached 206. 14 new special medical foods were added in the third quarter of 2024, all of which are domestically manufactured products, including 6 full nutritional products, 6 non-full nutritional products, and 2 special medical infant products

Founded in 2009, Asiaceutical Expo&Summit (AAES) is one of the most influential technology-oriented exhibitions in the nutrition and health industry in the Asia-Pacific. AAES gathers the global industrial development trends, domestic and overseas industry technology forces, global innovative ingredients and innovative products, providing enterprises with inspiration for product differentiation development, helping enterprises grasp industrial development opportunities, and building market competition barriers.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on food for special medical purpose (FSMP) to help you gain a clearer understanding of the current requirements in China.