14 Special Medical Foods Approved in the Third Quarter of 2024 – Analysis of 206 registered Formulas for Special Medical Purposes (FSMPs)

According to the information released by the Department of Special Food of the State Administration of Market Supervision, as of September 30, 2024, the number of domestic and foreign special medical foods that have been successfully registered in China has reached 206. 14 new special medical foods were added in the third quarter of 2024, all of which are domestically manufactured products, including 6 full nutritional products, 6 non-full nutritional products, and 2 special medical infant products, and the details of the new products are listed in the table below:

Table 1 List of new special medical foods added in the third quarter

FSMPs Registration Approval Status

As of September 30, 2024, a total of 206 special medical food registrations have been approved (of which 5 have applied for cancellation), with 174 domestically produced and 32 imported, and the number of domestically produced products registered has far exceeded that of imported products. Among the 206 approved products, most of them are powder, with 153 products in powder dosage form and the remaining 53 in liquid form.

1. Analysis of FSMPs registration types in the past years

Since the successful registration of the first special medical infant formula product in 2017, the door of special medical food registration has been officially opened. As can be seen from Figure 3, Infant FSMPs shows a trend of high start and low finish, and its registration is mainly concentrated in 2018 and 2019, while the registration of nutritionally complete food is concentrated in 2021 and 2023.In 2022, the total number of registrations is less, but the types of registered products increase, and the first nutritionally complete food is added.The first thickening component is added in 2023, and the types of registrations are mainly concentrated in nutritionally complete and nutritionally incomplete food, which accounted for 87% of the total. Compared with the number of registrations in 2022, 2023 has shown explosive growth. 42 new products have been approved in the first three quarters of 2024, which shows that the momentum of product approval in 2024 is strong, and there are already three nutritionally complete food and one amino acid metabolism disordered formula that have been announced for inclusion in the priority review and approval process.

The trend of types of FSMP registrations over the years is shown in the chart below:

Figure 3. FSMPs registrations over the years

2. Distribution of approved product types

From the perspective of product type, as shown in the figure below, 58 of the approved products are infant FSMPs, accounting for 28% of the total, including 5 milk protein deeply hydrolyzed formulas or amino acid formulas, 11 milk protein partially hydrolyzed formulas, 15 lactose-free or low-lactose formulas, 1 amino acid metabolism disordered formula, 20 preterm/low-birth-weight infant formulas, and 6 nutritional supplements; 82 were non-complete FSMPs, including 26 protein components, 2 fat components, 20 carbohydrate components, 24 electrolyte formulas, 4 thickening components, 4 fluid formulas, and 2 formulas for impaired metabolism of amino acids (1 year and older), representing 40% of the total; 65 were complete food formulas, representing 32% of the total, including 11 complete food formulas (1-10 years) and 54 complete food formulas (over 10 years old); only 1 specific complete food, namely Tacteasy Special Medical Use Tumor complete Food.

Note: For detailed information on the specific names, registered companies, registration numbers and expiration dates of the 206 products, please click on List of Registered Formulas for Special Medical Purposes (information on approvals is subject to the release of the official website).

Figure 4: Distribution of product types

Figure 5. Product Registrations by Category

Specific product registration information is listed below:

Table 2 Types of FSMPs and Corresponding Approvals

*Newly registered products in the third quarter are shown in red.

3. Analysis of declared enterprises

According to enterprises, a total of 58 enterprises have obtained the registration of FSMPs, and the number of domestic enterprises that have obtained the certificate of registration has reached 50. Nestle is still the enterprise with the largest number of approved products in China with a total of 15 products, followed by JIANGSU DAISY FSMP CO., LTD and Maifu Nutrition. Nestle, Abbott and Nutricia, as the world’s leading FSMPs companies, have products approved in both the non-infant FSMPs and infant FSMPs sectors. On the other hand, there is product homogenization phenomenon among domestic enterprises, such as domestic pharmaceutical enterprises mainly focusing on non-infant FSMPs, domestic dairy enterprises mainly focusing on infant FSMPs, and only some nutrition enterprises are involved in both infant FSMPs and non-infant FSMPs. From the point of view of the number of registered enterprises and products, the number of registered domestic enterprises and products continues to increase, and has long far exceeded the number of foreign enterprises and occupied a dominant position. At present, the registration of FSMPs is mainly concentrated in dairy, nutrition and health, pharmaceutical and other enterprises.

The specific situation of the number of products approved by each enterprise is shown in the following chart:

Figure 6. Number of Approved FSMPs by Enterprise

(Source: CIRS Group)

 

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