SAMR publishes registration guide for special medical foods for amino acid metabolism disorders
China
Feb 17, 2025
The State Administration for Market Regulation (SAMR) released a Guideline to Optimize the Registration of Foods for Special Medical Purposes (FSMP) Targeting Amino Acid Metabolism Disorders. The guideline aims to improve the registration efficiency and accessibility of FSMP products for patients with rare diseases.
The "Guidelines" are strictly based on the "Registration and Administration Measures for Formulated Foods for Special Medical Purposes" and clearly define the limits of non-metabolizable amino acids and the content of essential (including semi-essential) amino acids in products. Other nutrients, such as vitamins and minerals, can be appropriately adjusted based on the nutritional needs of the relevant population. At the same time, the "Guidelines" also clarify the corresponding technical requirements in terms of production processes, R&D capabilities, production capabilities, product labeling and instructions, etc., providing detailed and comprehensive guidance for enterprises to declare corresponding products.
For further information (in Chinese), click on the Link
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