Annual Review of Registration Approvals of China Special Medical Purposes Foods in 2025

As of December 31, 2025, a total of 59 Foods for Special Medical Purposes (FSMPs) were approved in 2025, bringing the cumulative number of approved FSMPs in China to 290.

CIRS conducted a comprehensive statistical summary of the 59 FSMPs approved in 2025 and carried out multi-dimensional analyses to provide insights and references for enterprises.

1. General Situation of FSMPs Registration Approvals in 2025

In 2025, out of the approved special medical purpose foods, 54 were domestic products, accounting for 92%; and five were imported products, accounting for 8%. The number of domestic product registrations far exceeded that of imported products. In terms of product dosage forms, powder products were the most common, with a total of 45, accounting for 76%; and 14 were liquid products, accounting for 24%.

Figure 1. General Situation of FSMPs Food Registration Approvals in 2025

2. Number of FSMP Registrations Approved in 2025 (by Approval Time)

The distribution of registration approval times for FSMPs in 2025 is shown in Figure 2. From the chart, it can be seen that, with the exception of a few months, a certain number of products were approved almost every month throughout the year. This indicates that, on the one hand, enterprises and R&D institutions continue to show strong interest in this field and actively submit applications; on the other hand, regulatory authorities have significantly accelerated the review and approval process, with continuously improved efficiency, providing strong support for the stable development of the industry.

Figure 2. Monthly Number of FSMP Registrations Approved in 2025

3. Number of FSMP Registrations Approved in 2025 (by Product Category)

As shown in Figure 3 below, among the FSMPs approved for registration in 2025, the number of complete nutrition formula foods was the highest, with a total of 27, accounting for 46% of the total approved number; followed by protein (amino acid) components, with a total of 12, accounting for 20% of the total approved number.

At the same time, it can be observed that some product categories did not have new products approved in 2025, such as extensively hydrolyzed milk protein formulas, amino acid formuls and specific complete nutrition formulas.

Figure 3. Number of Registrations Approved for Different Categories of FSMPs in 2025

4. Number of FSMPs Registrations Approved in 2025 (by Target Population)

As shown in Figure 4 below, among the FSMPs approved for registration in 2025, the largest number of products (33) were intended for people aged ten years and above. Followed by 12 products intended for infants aged 1-10 months, five products intended for people aged one year and above, four products intended for infants aged 0-12 months. Overall, the approved products demonstrate coverage across the entire life cycle while also addressing key population groups. In particular, products targeting adults account for a significant proportion, indicating that enterprises are shifting their strategic focus toward the needs of specific physiological stages and chronic disease management.

Figure 4. Number of Registrations Approved for FSMPs by Target Population in 2025

5. Number of FSMP Registrations Approved in 2025 (by Province/Region)

The 59 FSMPs approved for registration in 2025 came from 19 different provinces and regions. Jiangsu, Shandong, and Guangdong provinces ranked top three with eight, seven, and seven products respectively, accounting for 14%, 12%, and 12% of the total approved number. For specific provinces and regions along with their data, see Figure 5 below.

Figure 5. Number of Registrations Approved for FSMPs by Province/Region in 2025

6. Number of FSMP Registrations Approved in 2025 (by Applicant Unit)

The 59 FSMPs approved for registration in 2025 involved 40 applicant units. As shown in Figure 6 below, Zhejiang Yisu Element, Hong Kong Meiya FSMP, and Jilin Maifu Nutrition each received four FSMP approvals in 2025, ranking in the first tier. Following closely, Qingdao Shengtong Nutrition obtained three FSMP approvals. Additionally, eight companies each secured two approvals, while the remaining 28 companies received one approval each.

This indicates that there was a relatively diverse enterprise distribution for FSMP approvals in 2025, reflecting a diversified market participation. Notably, in addition to traditional pharmaceutical and dairy companies, several technology-oriented firms and medical nutrition enterprises are actively entering the field, highlighting that the FSMP sector is attracting cross-industry participation from companies in nutrition, health, and biotechnology.

Figure 6. Top Companies by Number of FSMP Registrations Approved in 2025

CIRS Analysis

Currently, FSMPs have begun to achieve broad category coverage, but significant product gaps in niche areas remain, such as complete nutrition formulas for specific populations and amino acid metabolism disorder formulas. With the improvement of relevant technical guidelines and the gradual implementation of priority review policies, it is expected that FSMPs addressing rare diseases, chronic conditions, and other special medical needs will see an accelerated approval and market entry in the future.

In 2025, China's SAMR issued a series of standards and guidelines to optimize the FSMP registration process and provide support for enterprises. A summary of the relevant updates is presented in the table below:

Note:

1. Data Source: Special Food Information Inquiry Platform.

2. There may be a delay in the release of data from the Special Food Information Inquiry Platform. The data in this article is for reference only, and the actual situation should be based on official announcements.

3. For reference, an example registration number is: 国食注字TY2025XXXX

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