[FAQs] Latest Summary of Application Issues on FSMP

To accurately address the common questions frequently encountered in the acceptance of special foods and related administrative licenses, and to effectively improve applicants’ efficiency and experience, the Food Review Center of the State Administration for Market Regulation issued the “Summary of Common Issues on the Acceptance Work” on October 28, 2025.

This article forms part of a series of FAQs we have translated and focuses on the application of food for special medical purposes in China. Other articles include FAQs on health food acceptance and the application of infant formula products in China.

1. Can Foods for Special Medical Purposes (FSMP) changes, renewals, and cancellations be submitted through the registration system?

Answer: Before submitting an application, enterprises should carefully review the product list that has already been migrated to the new registration system (see “List of Products for Which Changes, Renewals, and Cancellations Should Be Processed in the New Registration System” on the system’s application interface; this list is continuously updated according to data migration progress).

Enterprises must strictly follow the requirements below and select the correct information system for their applications:

For products included in the above list, the business data have already been migrated to the new registration system; enterprises should use the new system to submit applications for changes, renewals, and cancellations.

For products not included in the above list, the business data remain in the old registration system; enterprises should use the old system for changes, renewals, and cancellations.

2. The registration certificate for FSMP expires soon. The regulation states that if continuation of production or import is required, a renewal application must be submitted to SAMR six months before expiry. Does this mean the application only needs to be submitted within six months prior to expiry?

Answer: The requirement refers to submission and acceptance of the application within that six-month period.

3. In the system, the address shown on the Supplement Notice is “Building 29, Zone 12, No.188 West Road of South Fourth Ring Road, Fengtai District, Beijing.” Is this contact address still valid?

Answer: A small number of notices may display an incorrect submission address generated by the system.

Please use the correct mailing address:

1st Floor, Block C, No. 8 Sanlihe East Road, Xicheng District, Beijing

Contact number: 010-88650123

4. Is sample submission required?

Answer: No.

5. How many copies of the locked clinical trial database CD-ROM must be submitted for specific complete-nutrition FSMP clinical trials?

Answer: Two copies of the locked clinical trial database CD-ROM are required.

About CIRS Group

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 domestic and international food companies achieve one-stop compliance solutions. CIRS offers a full range of regulatory services covering novel food applications, synthetic biology-derived foods, U.S. GRAS notice, EU novel food application, health food registration, and food for special medical purposes (FSMP).

Our food services in China include, but are not limited to:

• China FCM Testing
• China new food raw materials registration
• China new food additive registration
• China health food (dietary supplement) registration/filing
• China health food testing service
• China new food contact substance registration
• China food for special medical purpose (FSMP) registration
• China infant formula milk powder registration

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.