China’s SAMR Released Guidelines to Simplify FSMP Registration

The State Administration for Market Regulation (SAMR) of China has recently issued several new guidelines to simplify the registration process for three categories of foods for special medical purposes (FSMP), including:

• electrolyte formula;
• carbohydrate component formula; and
• protein component formula.

These guidelines aim to facilitate FSMP registration and meet the nutritional needs of special populations.

Background

In November 2023, the SAMR revised and published the Administrative Measures for Registration of Foods for Special Medical Purpose Registration ("the Measures”). To further optimize the registration process and meet the needs of special populations, the new guidelines were created based on scientific understanding, registration practices, and product development for the three FSMP categories. These measures also reinforce food safety responsibilities for enterprises.

Scope of application

The guidelines stipulate that applicants of the above three types of FSMP products must follow the requirements of the revised Measures and relevant regulations. They can optimize their materials under specific conditions outlined in the guidelines, which generally eliminates the need for on-site inspections and sample testing during the registration process.

Key optimizations in application materials

• Product formula design: Applicants only need to submit a conformity statement for the product formula, without providing the detailed basis for the design.
• Production process design: For applications that meet the relevant conditions outlined in the guidelines, applicants only need to submit a consistency statement regarding the process design, form selection, and process details when applying for registration. There is no need to provide the basis for the production process design or related documentation.
• Stability studies: Applicants are required to conduct stability studies as per the requirements and submit a statement that includes the timeline, rather than a full research report.
• R&D and production capability: For cases that meet the guidelines, applicants only need to provide a statement regarding the R&D facilities, key production equipment, and quality management system. Original documents or proof of R&D and production capabilities are not required.
• Labeling and instructions: The guidelines clarify the labeling requirements for product names, formula characteristics, nutritional features, warnings, and usage instructions.

Conditions for on-site inspections and sample testing

The guidelines specify certain situations where on-site inspections and sample testing are necessary, such as the first-time registration of a product, the first use of a production line for FSMP, or in cases of non-compliance or reported issues. These measures are designed to ensure food safety while facilitating the registration process for compliant products.

Relationship with current regulations

The guidelines complement the current Measures by providing more detailed procedures and requirements for applicants. They ensure that the registration, stability studies, clinical trials, and labeling comply with established standards.

Future guidelines for other FSMP categories

These three categories of FSMP are well-established and have proven clinical use. Based on this, the registration process has been streamlined to reduce R&D costs, shorten approval times, and enhance review efficiency, thereby boosting market activity and meeting clinical needs.

For other types of FSMP, the SAMR will continue to develop guidelines based on specific product characteristics, common R&D issues, and industry needs to ensure product safety, nutritional adequacy, and clinical effectiveness.

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Further Information

【FSMP】 11 FSMPs Approved in China in the Second Quarter of 2024 – Bringing the Total to 192