The National Medical Products Administration (NMPA) has initiated a pilot program to implement “Priority review and approval procedures applied to formula foods for rare diseases and special medical purposes that are urgently needed in clinical practice.” According to the People\u2019s Daily, these procedures are expected to be incorporated into the Measures for Registration Administration of Formula Food for Special Medical Purposes. Notably, the review and approval timeframe for formulas for special medical purposes in rare diseases will be reduced to 30 working days from the previous 60, with on-site inspection and sampling inspection being given priority.<\/p>\n\n\n\n
Special Medical Purpose Foods: Meeting the Needs of Those with Special Dietary Requirements<\/strong> Rare Diseases and the Need for FSMP<\/strong>
Foods for Special Medical Purpose (FSMP) are specially processed and prepared to cater to the unique nutritional needs of individuals with limited eating, digestive and absorption disorders, metabolic disorders, or specific disease states. These foods play a critical role in managing health conditions that require tailored nutritional support.<\/p>\n\n\n\n
Among the 121 rare diseases listed by the government, 32 necessitate the use of FSMP, including 18 that require timely, lifelong, and sufficient use of FSMP which cannot be substituted by existing registered enteral nutrition preparations. These diseases include:<\/p>\n\n\n\n