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On February 12, 2025, China's State Administration for Market Regulation (SAMR) released a Guidance to optimize the registration of Foods for Special Medical Purposes (FSMP) targeting amino acid metabolism disorders. The document aims to enhance registration efficiency and improve accessibility of FSMP products for patients with rare diseases.
Regulatory Background
In China, all FSMP products must obtain registration approval under the Administrative Measures for Registration of Foods for Special Medical Purpose before entering the market.
According to these measures, FSMP products for amino acid metabolism disorders related to the following eight diseases can benefit from prior review and approval, as they are regarded as products for rare diseases:
Phenylketonuria (PKU)
Maple syrup urine disease
Propionic acidemia / Methylmalonic acidemia
Tyrosinemia
Homocystinuria
Glutaric acidemia type I
Isovaleric acidemia
Urea cycle disorders (UCD)
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Key Content of the Guidance
The Guidance refines registration requirements in the following aspects:
Application materials regarding product recipe design, production process, product stability as well as R&D capacity and production capacity
Product label and instruction sample
Onsite inspection and sampling examination
Specifically, the Guidance restricts the types and amounts of corresponding amino acids, aiming for either none or only a minimal amount of amino acids related to metabolic disorders in the recipe. The composition and amounts of other amino acids can be adjusted based on the specific disorder. Considering the nutritional needs of the PKU population, the Guidance requires that the amino acid formulation should include essential amino acids (8 types): isoleucine, leucine, lysine, threonine, tryptophan, valine, methionine, and histidine (essential for infants and children); and semi-essential amino acids (2 types): tyrosine and cystine.
Additionally, when applying for the registration of FSMP products for amino acid metabolism disorders, it is necessary to provide a statement regarding the co-production of related products, as well as specific measures taken to prevent cross-contamination. For applicants who have already received FSMP registration approvals on the same production line, only a consistency statement regarding the research and development institution, main facilities and equipment of the production site, and production quality management system is required.
On-site inspections and sampling examinations should be conducted according to Article 14 of the "Administrative Measures for the Registration of Special Medical Purpose Formula Foods." If the applicant has already received registration approvals for amino acid metabolism disorder FSMP, and the production process of the new application is consistent with the previous approval, on-site inspections of production are generally not required.
For further translation or consulting service, please email [email protected].
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