Background of formulation

In December 2023, the State Administration for Market Regulation revised and issued the Measures for the Registration and Administration of Food for Special Medical Purpose (hereinafter referred to as the Measures), newly adding provisions on priority review and approval, providing that applications for registration of food for special medical purpose for rare disease and new type of food for special medical purpose urgently needed clinically and not approved can apply for priority review and approval procedures. In order to further standardize the registration and administration of food for special medical purpose and better implement the provisions in the Measures on priority review and approval, the State Administration for Market Regulation formulated and issued the Working Procedures for Priority Review and Approval of Registration of Food for Special Medical Purpose, to further refine the specific requirements and processes for priority review and approval, and guide enterprises to strengthen product innovation and research and development for urgent need for clinical nutrition.

Scope of application

According to the Measures, the applicant applying for registration of food for special medical purpose can apply for priority review and approval procedures under any of the following circumstances: (1) Food for special medical purpose for rare disease; (2) New type of food for special medical purpose that is urgently needed clinically and has not yet been approved; (3) Other priority review and approval circumstances stipulated by the State Administration for Market Regulation.

How to manage?

Products with complete application materials and belonging to the scope of application of priority review and approval should be accepted in accordance with the priority review and approval procedure, and the products should be uniformly numbered according to the order of acceptance of food for special medical purpose, not numbered separately, and sorted separately according to the time included in the priority review and approval procedure.

Time requirement

The publicity time of product included in the priority review and approval procedure is 5 working days, the handling time limit for receiving objections is 10 working days, and the review time limit is 30 working days. Among them, the publicity time and opposition handling time are included in the review time limit and are calculated from the date of acceptance.

Source: SAMR

Note: This article is compiled by Antion. Please indicate the source for reprint.