CCTV News: On February 12, the State Administration for Market Regulation issued the "Guidelines for Registration of Formulas for Special Medical Purposes of Amino Acid Metabolic Disorders" (hereinafter referred to as the "Guidelines"), optimizing registration management requirements, guiding enterprises to develop and innovate, improving registration application efficiency, and promoting the accessibility of special medical foods for rare diseases.
Rare diseases of amino acid metabolism disorders include phenylketonuria, maple diabetes, propionemia/methylmalonicemia, tyrosinemia, homocystinuria, glutaricemia type I, isovalerate, urea circulation disorder and other categories. There is a lot of voice for patients with special medical foods with amino acid metabolism disorders and urgently need them in clinical practice. The State Administration for Market Regulation has included such products in the priority review and approval process.
The "Guidelines" strictly follow the "Regulations on the Registration and Management of Formulas for Special Medical Purpose Formulas", and clarify the limits of amino acids that cannot be metabolized in the product and the content of essential (including semi-essential) amino acids. For other nutrients such as vitamins and minerals, they can be appropriately adjusted according to the nutritional needs of the applicable population. At the same time, in terms of production processes, R&D capabilities, production capabilities, product labeling instructions, etc., the "Guidelines" also clarify the corresponding technical requirements, providing detailed and comprehensive guidance for enterprises to apply for corresponding products.
