China Streamlines the Registration of Food for Special Medical Purposes

On July 19, 2024, China State Administration for Market Regulation promulgated three Registration Guidelines for FSMP, covering electrolyte formula foods, carbohydrate component formula foods and protein component formula foods. These guidelines aim to streamline the registration process of these three kinds of FSMP products from the perspectives of documents submission and on-site inspection.

1. Document submission

(1) Formula design basis

Product formula design basis can be exempted for registration, and only the compliance statement about the product formula is required as long as the products meet the following requirements:

Products	Conditions for document exemption
Electrolyte formula foods	The main clinical purpose of the product is to serve as electrolytes supplement which should be based on carbohydrates and contain appropriate amounts of electrolytes. The target group is individuals with mild to moderate dehydration caused by diarrhea or other reasons. The formula of carbohydrate sources can generally include fructose, glucose, maltodextrin, etc. Sodium, potassium, and chloride should be added to the formula.
Carbohydrate component formula foods	The product should be composed of carbohydrates, aimed at supplementing carbohydrates and providing energy to people that require carbohydrate supplementation for specific diseases or medical conditions. Carbohydrate sources can include monosaccharides, disaccharides, oligosaccharides or polysaccharides, maltodextrin, glucose polymers, and other raw materials approved by laws and regulations. Other nutrients should not be added to the products. The use of food additives should have technical necessity and comply with the relevant requirements of GB29922, GB2760, etc. If the formula contains 12.5g of carbohydrates per 100mL in ready-to-eat condition, then its target group can be "people who need to supplement carbohydrates before surgery". The osmotic pressure should not exceed 320mOsmol/kg.

For protein component formula foods, if the proteins in the products are all sourced from premium protein such as whey protein powder and soybean protein isolate, and the protein content is over 80%, then the applicant only needs to submit the design basis of the usage and dosage of food additives and/or other auxiliary materials. Materials such as amino acid score of the aforementioned ingredients and products are not required.

(2) Production process design materials

While applying for the registration of electrolyte formula foods, carbohydrate component formula foods and protein component formula foods, applicants can benefit from a simplified process if they use the same production line of their previously approved FSMP products. In such cases, the applicant just needs to submit consistency statement regarding technique design & process, dosage form, etc. The design basis of the production technique and relevant literature sources are not required.

For protein component formula, an additional criterion applies. To qualify for the exemption from submitting production process design basis, these formulas should not only be produced on the same production lines of previously approved FSMP products, but also be produced through dry powder process.

(3) Stability research materials

While applying for the registration of electrolyte formula foods, carbohydrate component formula foods and protein component formula foods, the applicant only needs to submit the duration and relevant information of the stability test. The research report is not required.

However, the applicant should still carry out the stability research as per Stability Study Requirements for Foods for Special Medical Purpose (For Trial) and keep record.

(4) Research and production capability

While applying for the registration of electrolyte formula foods, carbohydrate component formula foods and protein component formula foods, for applicants who have already obtained registration approval for FSMP products manufactured on the same production line, they only need to submit a consistency statement regarding the research and development (R&D) institution, main facilities and equipment of the production site, as well as the production quality management system. However, they are not required to submit original documents and supporting materials for R&D and production capacities.

2. On-site inspection

The registration of electrolyte formula foods, carbohydrate component formula foods and protein component formula foods based on corresponding Registration Guideline are exempted from on-site inspection and sampling testing except the following situations:

(1) The applicant is applying for FSMP registration for the first time;

(2) The production line is being used for the first time for FSMP registration application;

(3) Other situations including:

Previous registration applications involving the concealment of true circumstances or providing false materials;
Relevant reports or cases where the supervisory and administrative departments deem inspections necessary;
Instances where on-site confirmation is deemed necessary during the technical review process.

FSMP industry promotion and future trend

In recent years, China has dedicated itself to the developing the FSMP industry. At the end of 2023, SAMR updated Administrative Measures for Registration of Foods for Special Medical Purpose, stipulating that FSMP for rare diseases and those in clinically urgent need would be eligible for priority review.

According to the official interpretation on the latest announcement, more and more registration guidelines of FSMP products will be drafted to guide the R&D, production and technical review. The optimized supervision mechanism is anticipated to stimulate the FSMP market significantly and better meet clinical demands.