On July 19, 2024, China State Administration for Market Regulation promulgated three Registration Guidelines for foods for special medical purpose (FSMP), specifically targeting electrolyte formula foods, carbohydrate component formula foods and protein component formula foods. These guidelines aim to streamline the registration process of these three kinds of FSMP products from the perspectives of documents submission and on-site inspection. Subsequently, on July 21, 2024, China SAMR issued a notice providing interpretative guidance to accompany these Guidelines.
These Guidelines are formulated under the Administrative Measures for Registration of Foods for Special Medical Purpose and relevant regulations, aiming to reduce the cost of enterprise research and development, shorten the registration time, better meet the clinical nutritional needs of patients, and promote the high-quality development of the special medical food industry.
What is FSMP?
Under the Food Safety Law, food is categorized into general and special food, the latter including health food, food for special medical purpose (FSMP), and infant formula food. FSMP is specially processed and formulated to meet the unique nutritional or dietary needs of individuals with dietary restrictions, digestive and absorption disorders, metabolic disorders, or specific diseases.
Registration Approval of FSMP
As of July 1, 2024, a total of 192 FSMP products have been approved for registration, with 5 of these having applied for cancellation. Of the 192 approved products, 159 are domestic, and 33 are imported, with the number of domestic registrations significantly exceeding that of imported products. Besides, the majority of the 192 products are in powdered form, accounting for 141, while the remaining 51 are liquid products.
Regarding product types, 56 of the approved products are infant FSMP, accounting for 29% of the total; 76 products are incomplete nutritional formula food, making up 40%; 59 products are full nutritional formula food, constituting 31%. There is only one product classified as a specific full nutritional formula food.
