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On October 22, 2024, China State Administration for Market Regulation (SAMR) unveiled the Working Procedures for Priority Review and Approval of Foods for Special Medical Purposes Registration (hereinafter the “Working Procedures”), detailing the eligible scope and the application steps of priority review. the Working Procedure has been in effect since the date of promulgation.
Eligible scope
The following FSMP products can enjoy priority review of their registration:
1) FSMP products for rare diseases, such as phenylketonuria, maple syrup urine disease, methylmalonic acidemia, tyrosinemia, homocystinuria, glutaric acidemia type I, isovaleric acidemia, and urea cycle disorders.
2) New types of FSMP products that are urgently needed in clinical practice while have not been approved yet, such as complete nutrition formula for diabetes, respiratory diseases, kidney diseases, liver diseases, sarcopenia, trauma, infection, surgery and/or other stressful conditions, inflammatory bowel disease, food protein allergy, refractory epilepsy, gastrointestinal absorption disorders, pancreatitis, abnormal fatty acid metabolism, obesity and/or fat reduction surgery.
3) Other circumstances for priority review as stipulated by SAMR.
Application steps
The application procedure of FSMP priority review includes four main steps, which are application submission, acceptance publication, technical review, and results delivery.
Upon submission of an application, the SAMR Food Review Center will first conduct a preliminary document review. If the application materials are complete and the product falls within the eligible scope, the product information and grounds for acceptance will be publicly disclosed for 5 working days. In the absence of any objections during this disclosure period, the Food Review Center will proceed with technical review and expert verification, which should be completed within 30 working days. If at any point the application is determined to fall outside the scope of priority review, the priority review process will be terminated. The applicant may continue with the registration process through the standard review pathway.
Flowchart for the priority review of FSMP products in China
FSMP priority review was first officially introduced in the Administrative Measures for Registration of Foods for Special Medical Purpose updated in December 2023 (check China Revises Administrative Measures for FSMP Registration for more details). This initiative aims to accelerate the development and approval of products that address urgent clinical needs. To facilitate implementation of the priority review policy, the SAMR established the detailed Working Procedures to guide applicants through the process. Enterprises interested in applying for FSMP priority review can seek further guidance from Food Review Center via [email protected].
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