On February 12, the State Administration for Market Regulation (SAMR) released the Guidelines for Registration of Special Medical Foods for Amino Acid Metabolic Disorders. These guidelines aim to optimize registration requirements, guide companies in R&D innovation, improve the efficiency of registration applications, and enhance the accessibility of special medical foods for rare diseases.
Amino acid metabolic disorders include phenylketonuria, maple syrup urine disease, propionic acidemia/methylmalonic acidemia, tyrosinemia, homocystinuria, succinic aciduria type I, isovaleric acidemia, urea cycle disorders, and more. The SAMR has prioritized the review and approval of these products due to high patient demand and clinical need. The Guidelines clarify product limits for non-metabolized amino acids and required (including semi-essential) amino acids, with adjustments for other nutrients like vitamins and minerals based on the target population’s needs. Additionally, the guidelines set technical requirements for production processes, R&D, production capacity, and product labeling to provide comprehensive support for companies applying for these products. (Source: SAMR)
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