Food for special medical purpose (hereinafter referred to as FSMP) are a type of special food and are subject to strict supervision and management by China. FSMP should be registered with the food safety supervision department of the State Council. According to the registration and approval information for FSMP released on the "Special Food Information Inquiry Platform" published by the State Administration for Market Regulation, as of December 31, 2024, there are 214 products that have obtained registration and approval in China, including 32 imported FSMP and 182 domestic FSMP. In 2024, 50 new products were approved, 49 of which were domestic FSMP and 1 was an imported FSMP. In order to facilitate the understanding of registration of FSMP, Antion analyzed the product registration, product categories, place of origin and product form over the years for enterprises' reference.

01 Product Registration over the Years

The registration and approval system for FSMP has been implemented for 8 years from 2017 to 2024. The followings analyzed the registration of FSMP over the years from the aspects of the number of FSMP registered and approved over the years and product categories, as shown in Figure 1.

Figure 1 Number of registered special medical foods over the years

As can be seen from Figure 1, China's FSMP industry has flourished in recent years, and the number of domestically approved products has increased significantly. Initially, all approved products were imported products, but after 2019, domestically approved products continued to dominate. From 2017 to 2019, the number of registered and approved imported FSMP was significantly higher than that of registered and approved domestic FSMP; From 2019 to 2024, the number of registered and approved domestic FSMP was significantly higher than that of registered and approved imported FSMP. In 2024, 50 products were approved, of which 49 are domestic FSMP and 1 is imported FSMP.

FSMP can be divided into two categories according to the use population: infant formula FSMP for infants aged 0 to 12 months and FSMP for people over 1 year old. FSMP for people over 1 year old can be further divided into complete nutrition formula, specialized complete nutrition formula and partial nutrition formula.

Figure 2 Product Categories of FSMP over the Years

As can be seen from Figure 2, in recent years, the number of infant formula FSMP approved and registered is relatively small, the number of partial nutrition formula and complete nutrition formula approved and registered is relatively large, and only one specialized complete nutrition formula has been approved.

02 Product Category

Figure 3 Proportion of product categories of FSMP

As can be seen from Figure 3, from 2017 to 2024, among 214 approved FSMP, 87 are partial nutrition formula, accounting for 41% of the total, 67 are complete nutrition formula, accounting for 31% of the total, 1 is specialized complete nutrition formula, accounting for 0.4% of the total, and 59 products are infant formula FSMP, accounting for 27.6% of the total. 59 approved infant formula FSMP include 1 amino acid metabolism disorder formula, 1 low lactose formula, 6 breast milk nutritional supplements, 14 lactose-free formula foods, 16 milk protein hydrolysis/ amino acid formula and 21 premature/ low birth weight infant formula.

Among the approved FSMP in 2024, 25 products are partial nutrition formula, accounting for 50% of the total, 14 products are complete nutrition formula, accounting for 28% of the total, and 11 products are infant formula FSMP, accounting for 22% of the total. 11 approved infant formula FSMP include 2 breast milk nutritional supplements, 1 lactose-free formula, 2 milk protein hydrolysis/ amino acid formula and 6 premature/ low birth weight infant formula.

03 Place of Origin

From 2017 to 2024, among the approved FSMP, there are 182 domestic products and 32 imported products. As shown in Figure 4, the approved FSMP are mainly located in Jiangsu, Shandong and Zhejiang, accounting for 54% of the total.

Among the approved FSMP in 2024, there are 49 domestic products and 1 imported product. As shown in Figure 4, the approved domestic FSMP in 2024 are mainly located in Jiangsu, Heilongjiang and Shandong, accounting for 57% of the total.

Figure 4 Provinces where FSMP are approved domestically

04 Product Form

From 2017 to 2024, among the 214 types of FSMP registered and approved, the majority are solid products, of which 158 products are solid, accounting for 74% of the total, and 56 products are liquid, accounting for 26% of the total. Of the 50 products approved in 2024, 36 are solid products, accounting for 72% of the total, and 14 are liquid products, accounting for 28% of the total. It can be seen that solid products still occupy the dominant position of product form in 2024, which is consistent with the distribution of product form of FSMP over the years.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.