On October 22, the State Administration for Market Regulation of China (SAMR) released the "Working Procedures for the Priority Review and Approval of the Registration of Formulated Foods for Special Medical Purposes" (hereinafter referred to as the "Working Procedures"), further regulating the priority review and approval process for the registration of formulated foods for special medical purposes (hereinafter referred to as "FSMP"), guiding enterprises to increase innovative research and development of FSMP for rare diseases and new types of FSMP urgently needed in clinical settings, and better meeting the clinical nutritional needs of patients.

The "Working Procedures" detail the specific processes and requirements for priority review and approval, clarifying that FSMP for rare diseases such as phenylketonuria and specific full-nutrition formulated foods urgently needed for clinical conditions such as diabetes and kidney disease that have not been approved can be subject to priority review and approval, facilitating the process for registration applicants and review departments. The "Working Procedures" specify that the public notification period for inclusion in the priority review and approval process is 5 working days, the time limit for handling objections is 10 working days, the time limit for registration review is shortened to 30 working days, and on-site production inspections, sampling inspections, and on-site clinical trial inspections are prioritized as needed.

The "Working Procedures" also emphasize that the review department should actively communicate with applicants and can arrange special exchanges when necessary, which helps to shorten the time for applicants to correct materials, improve the quality of corrected materials, and enhance the working efficiency of the review department.