On October 22, 2024, China's State Administration for Market Regulation (SAMR) released the Working Procedures for Priority Review and Approval of Registration for Food for Special Medical Purposes(FSMP) (hereinafter referred to as "Working Procedures"), effective immediately. This document is formulated based on the Administrative Measures for Registration of Foods for Special Medical Purposes(hereinafter referred to as "Measures") and related regulations, aiming to encourage research and innovation, meet urgent clinical nutritional needs, and standardize the prioritized review and approval process for FSMP registration.
On the same day, China SAMR provided a policy interpretation of this document, detailing the following key points:
1. What is the background for the development of the Working Procedures?
In December 2023, China SAMR revised the Measures, introducing prioritized review and approval Working Procedures for registering FSMP products. This applies specifically to FSMP products for rare diseases and new types that are urgently needed in clinical settings but have not yet received approval.
To standardize FSMP registration management and effectively implement these prioritized provisions, the SAMR developed the Working Procedures based on the unique characteristics of FSMP registration. This initiative is informed by extensive research and feedback from regulatory bodies, industry associations, and companies. The goal is to clarify the requirements and processes for prioritized review and approval, encouraging companies to innovate and develop products that meet urgent clinical nutritional needs.
2. What are the main contents of the Working Procedures?
The Working Procedures outline the specific processes for implementing the prioritized review and approval policy established in the Measures. They consist of three main sections: applicable scope, work Working Procedures, and implementation requirements. The Working Procedures provide detailed requirements and steps for application registration, acceptance announcements, review and verification, and termination Working Procedures. Additionally, approval application forms and objection forms have been created to assist FSMP companies and stakeholders in meeting these requirements.
3. How will products included in the prioritized review and approval Working Procedures be managed?
Products with complete application materials that qualify for prioritized review and approval will be accepted and managed under a unified numbering system. This system organizes FSMP products based on the order of acceptance and sorts them according to their inclusion in the prioritized review and approval Working Procedures.
4. What are the specific time requirements for products included in the prioritized review and approval Working Procedures?
The review period for products included in the prioritized review and approval process is 30 working days, starting from the date of acceptance. This period encompasses a public announcement phase of 5 working days and a time-frame of 10 working days for addressing any objections received.
5. What categories of products can apply for the prioritized review and approval Working Procedures?
According to the Measures, applicants for FSMP registration can apply for prioritized review and approval under the following circumstances: (1) FSMP products for rare diseases; (2) new types of FSMP products urgently needed in clinical settings that have not yet been approved; (3) other situations designated by the SAMR for prioritized review and approval.
Currently eligible categories mainly include:
1. FSMP products for rare diseases such as Phenylketonuria, Maple Syrup Urine Disease, Propionic Acidemia, Methylmalonic Acidemias, Tyrosinemia, Homocystinuria, Succinic Acidemia Type I, Isovaleric Acidemia, and Urea Cycle Disorders.
2. New types of products urgently needed in clinical settings, including complete nutritional formulas for diabetes, respiratory diseases, kidney diseases, liver diseases, muscle wasting syndrome, trauma, infections, surgical recovery, inflammatory bowel disease, food protein allergies, intractable epilepsy, gastrointestinal absorption disorders, pancreatitis, fatty acid metabolism disorders, obesity, and post-bariatric surgery.
For applications involving other product categories seeking prioritized review and approval, applicants are encouraged to consult with the Center for Food Evaluation(CFE) of the SAMR prior to submission.
6. How can applicants communicate with the Center for Food Evaluation of the SAMR ?
The CFE of the SAMR has established a dedicated email address (tyyxsp@cfe-samr.org.cn) for products applying for prioritized review and approval Working Procedures. Organizations or individuals with objections to public announcement items can send their objection content to this email. For inquiries, relevant questions and information—including product name, acceptance number, inquiry details, questions, and contact information—can also be directed to this email. The CFE will assign personnel to monitor the inbox and contact applicants as needed.
As a leading third-party compliance service provider in China, ZMUni Compliance Centre can assist businesses in applying Food for Special Medical Purposes Registration in China. If you have any further inquiries, feel free to contact us at info@zmuni.com.