CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.

Q1: Is batch testing required for FSMP modules?

A1: Yes. As stipulated in the Administrative Measures for Foods for Special Medical Purpose Registration (hereinafter referred to as the Measures), the applicant should conduct batch testing on the finished products according to relevant laws and regulations, and national food safety standards and technical requirements. Therefore, batch testing is required for all types of finished FSMP products.

Q2: Is on-site inspection required when an overseas production company applies for FSMP?

A2: Generally speaking, on-site inspection is required, especially for new applicants.

It is explicitly stipulated in the Measures that the review agency should conduct on-site inspection and sampling testing based on food safety risks, and carry out on-site inspection of clinical trials. If necessary, extended inspections may be conducted on food raw materials and additives manufacturers.

The time frame for overseas on-site inspections and sampling inspections is subject to actual circumstances.

Q3: Does the applicant for FSMP need to have their own research and development center and production line? Is entrusted production allowed?

A3: Yes, and the production cannot be entrusted.

According to the Measures and its interpretative documents, the applicant should be a production enterprise intending to produce and sell FSMP within the People’s Republic of China, or an overseas production enterprise intending to export FSMP to the People’s Republic of China. Additionally, the applicant must possess corresponding research and development capabilities and production capacity to establish a FSMP research institution and a production quality management system in accordance with good manufacturing practice requirements.

Q4: What are the requirements for FSMP production factories?

A4: They should comply with GB 14881 National Food Safety Standard - General Hygiene Practice in Food Production and GB 29923 National Food Safety Standard - Good Manufacturing Practice for Foods for Special Medical Purpose, among other requirements.

Q5: Are there any other policy documents besides the Measures concerning the priority review and approval of FSMP?

A5: Currently, no.

As specified in the Measure, the applicant may apply for the priority review and approval procedures for FSMP if one of the following conditions is met:

1. FSMP for rare diseases;
2. FSMP urgently needed in clinical practice and not yet approved; and
3. Other conditions specified by SAMR.

Before filing a registration application, the applicant should communicate with the evaluation agency. Once confirmed, the applicant should simultaneously submit a request for priority review and approval along with the registration application to the evaluation agency. After review and confirmation of compliance with the aforementioned provisions, and upon no objections during the public announcement phase, the evaluation agency will include the application into the priority review and approval process. The approval timeline is shortened from 60 working days to 30 working days, enabling prioritized scheduling of on-site inspections and sampling inspections.

For more information, click here to learn about our FSMP registration service.

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

Further information

CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Heath Food Filing? Vol. 3, 2024