Two foods for special medical purpose for children with rare diseases such as phenylketonuria, methylmalonic acidemia and propionic acidemia were registered, achieving a breakthrough of zero domestic product, which is conducive to improving the accessibility of foods for special medical purpose for rare diseases. This is the first batch of products that the State Administration for Market Regulation applies the priority review and approval procedure for fast approval, and its review time is shortened from 60 working days to 20 working days, and priority is given to on-site verification and sampling testing.

Phenylketonuria, methylmalonic acidemia and propionic acidemia are all amino acid metabolism disorder rare diseases. The incidence of phenylketonuria is about 1/10000, that of methylmalonic acidemia is about 1/15000 and that of propionic acidemia is about 1/200000. Food for special medical purpose is the main treatment method in the clinical treatment of such rare diseases, and patients need to use food for special medical purpose in time, life and sufficient amount.

Source: SAMR

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