China Prioritizes Review and Approval for FSMP for Rare Diseases

SAMR is currently trialing a priority review for FSMP for rare diseases, and plans to add relevant contents in the future revision of Administrative Measures for FSMP Registration. 18 rare diseases related to the use of FSMP foods are listed in the China's First Batch of Rare Diseases.

According to an official media release on September 12, 2023, State Administration for Market Regulation (SAMR) plans to revise the Administrative Measures for Registration of Foods for Special Medical Purpose, shortening the review period for urgent clinical needs related to FSMP for rare diseases from 60 to 30 working days, and prioritizing the on-site inspections and sample testing for these FSMP products. Also, SAMR is currently trialing this priority review and approval process.

FSMP foods serve as the core component of clinical care. During the treatment for the 18 rare diseases listed in the China's First Batch of Rare Diseases Catalogue, timely, lifelong, and adequate access to FSMP foods is indispensable. For diseases like phenylketonuria (PKU), patients rely on FSMP food products for normal growth and development. Without timely treatment, patients risk developmental delays, disabilities, and even death.

The 18 rare diseases that require the use of FSMP products in China's First Batch of Rare Diseases Catalogue are summarized as follows.

Rare diseases	FSMP product type
Arginase Deficiency	Amino acid metabolism disorder formula
Citrullinemia	Amino acid metabolism disorder formula
Galactosemia	Specific nutritionally complete foods; Nutritionally incomplete foods
Glutaric Acidemia Type I	Amino acid metabolism disorder formula
Glycogen Storage Disease (Type I、II）	Carbohydrate components
Homocysteinemia	Amino acid metabolism disorder formula
Hyperornithinaemia-Hyperammonaemia-Homocitrullinuria Syndrome	Amino acid metabolism disorder formula
Isovaleric Acidemia	Amino acid metabolism disorder formula
Long Chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency	Fat components; Nutritionally complete food for fatty acid metabolism disorder patients
Maple Syrup Urine Disease	Amino acid metabolism disorder formula
Methylmalonic Academia	Amino acid metabolism disorder formula
N-acetylglutamate Synthase Deficiency	Amino acid metabolism disorder formula
Ornithine Transcarbamylase Deficiency	Amino acid metabolism disorder formula
Phenylketonuria	Amino acid metabolism disorder formula
Propionic Acidemia	Amino acid metabolism disorder formula
Severe Myoclonic Epilepsy in Infancy (Dravet Syndrome)	Ketogenic formula； Nutritionally complete food for intractable epilepsy patients
Tyrosinemia	Amino acid metabolism disorder formula
Very Long Chain Acyl-CoA Dehydrogenase Deficiency	Fat components; Nutritionally complete food for fatty acid metabolism disorder patients

Please check the following articles for the detailed framework for FSMP product types in China:

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