Recently, two specialized medical foods designed for children with rare metabolic disorders, phenylketonuria (PKU), methylmalonic acidemia (MMA), and propionic acidemia (PA), have successfully obtained product registration. This marks a significant milestone in China, achieving the first domestically registered products in this category, which will improve the accessibility of medical nutrition for rare disease patients.
These products were among the first to undergo the priority review and approval process by SAMR, reducing the evaluation period from 60 to 20 working days, with expedited on-site inspections and sample testing.
– Phenylketonuria (PKU): Affects approximately 1 in 10,000 individuals.
– Methylmalonic Acidemia (MMA): Affects approximately 1 in 15,000 individuals.
– Propionic Acidemia (PA): Affects approximately 1 in 200,000 individuals.
Medical foods play a crucial role in the clinical management of such rare diseases, requiring lifelong, adequate intake to ensure effective treatment. (Source: SAMR)
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