Updated on July 4, 2024
According to the information from the Special Food Division of the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 192 by July 1, 2024. In the second quarter of 2024, 11 domestic FSMPs have been approved, including three nutritionally complete products, six nutritionally incomplete products, and two infant formula for special medical purposes. Details are given in the table below:
Table 1. FSMPs approved in the second quarter of 2024
S.N. | Applicant | Product name | Dosage form | Certificate number | Valid until |
1 | Fresenius Kabi Huarui Pharmaceutical Co., Ltd. | 德瑞清® liquid formula for special medical purposes | Liquid | 国食注字TY20240017 | 2029.4.1 |
2 | JIANGSU DAISY FSMP CO., LTD | 冬泽益全nutritionally complete food for special medical purposes | Liquid | 国食注字TY20240018 | 2029.4.1 |
3 | JIANGSU DAISY FSMP CO., LTD | 冬泽力亮protein formula for special medical purposes | Liquid | 国食注字TY20240019 | 2029.4.1 |
4 | JIANGSU DAISY FSMP CO., LTD | 冬泽益能fat formula for special medical purposes | Powder | 国食注字TY20240020 | 2029.4.1 |
5 | Shandong Ruoyao FSMP Co. LTD | 若宁thickening components for special medical purposes | Powder | 国食注字TY20240021 | 2029.4.1 |
6 | Nestlé Health Sciences (China) Co., Ltd. | 佰态能nutritionally complete food for special medical purposes | Liquid | 国食注字TY20240022 | 2029.5.16 |
7 | Du’erbote Yili Dairy Co. LTD | 托菲儿早护preterm/low birth weight infant formula for special medical purposes | Powder | 国食注字TY20240023 | 2029.5.16 |
8 | Du’erbote Yili Dairy Co. LTD | 托菲儿早护preterm/low birth weight infant formula for special medical purposes | Powder | 国食注字TY20240024 | 2029.5.16 |
9 | Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd. | 海维甘® nutritionally complete food for special medical purposes | Liquid | 国食注字TY20240025 | 2029.5.16 |
10 | Guizhou Jinjiu Biotech Co., Ltd | 金康宜® electrolyte formula for special medical purposes | Liquid | 国食注字TY20240026 | 2029.5.16 |
11 | Guizhou Jinjiu Biotech Co., Ltd | 玖康益® carbohydrate formula for special medical purposes | Liquid | 国食注字TY20240027 | 2029.5.16 |
FSMP registration and approval status
As of July 1, 2024, a total of 192 FSMPs have obtained approval (with five having applied for cancellation). Of these, 159 are domestically produced and 33 are imported. Notably, among the approved products, the majority (141) are in powdered form, with the remaining 51 being liquid products.
Figure. 1 Distribution of domestic and imported FSMP
Figure. 2 Distribution of FSMP product forms
Analysis of previously registered FSMP types
Since the first infant formula for special medical purposes was successfully registered in 2017, the pathway for FSMP registration has officially opened. As shown in Figure 3, registrations for infant formula for special medical purposes experienced a strong start but later declined, with most registrations occurring in 2018 and 2019. Registrations for nutritionally incomplete formulas, on the other hand, were mainly concentrated in 2021 and 2023.
In 2022, the total number of registrations was relatively low, but the registered product types increased, including the first specific nutritionally complete formula.
In 2023, the first thickening component was introduced, with registrations primarily focusing on nutritionally complete and incomplete products, which together accounted for 87% of the total. Compared to the registration volume in 2022, 2023 showed explosive growth. In the first and second quarters of 2024, 17 and 11 new products were added respectively, indicating a strong momentum for approvals in 2024. Additionally, three specific nutritionally complete foods and one amino acid metabolism disorder formula have been included in the priority review and approval process.
The trend of registered types of FSMP over the years is shown in the figure below:
Figure. 3 FSMP registrations over the years
Distribution of approved product types
In terms of product types, as shown in the figure below, there are 56 infant formulas for special medical purposes, making up 29% of the total. These include five extensively hydrolyzed protein or amino acid formulas, 11 partially hydrolyzed protein formulas, 15 lactose-free or low-lactose formulas, one amino acid metabolism disorder formula, 19 preterm/low birth weight infant formulas, and five nutrition supplements. 76 are nutritionally incomplete foods, including 22 protein components, two fat components, 19 carbohydrate components, 24 electrolyte formulas, three thickening components, four liquid formulas, and two amino acid metabolism disorder formulas (for individuals over one year old), accounting for 40% of the total. The remaining 59 are nutritionally complete foods, accounting for 31% of the total. These include ten nutritionally complete foods designed for children aged 1-10 and 49 for individuals aged 10 and above. There is only one specific nutritionally complete food: Su Yisu oncology nutritionally complete food for special medical purposes.
Note: For detailed information on the names, applicants, registration numbers, and validity period of the 192 products, please click here to check out the latest list of registered FSMP products (approval information is subject to updates on the official website).
Figure. 4 Distribution of product types
Figure. 5 Registration volume of various products
Details are as follows:
Table 2. FSMP product types and approval status
Category/type | Number of approval | Product/Company | Target population | ||
---|---|---|---|---|---|
Infant formula for special medical purpose | Extensively hydrolyzed milk protein formula or amino acid-based formula food | 5 | Neocate / SHS | 0-12 months | |
ALFARE/ NESTLE | |||||
Althera/NESTLE | |||||
ALFAMINO/ NESTLE | |||||
Pepti Junior/Nutricia | |||||
Partially hydrolyzed milk protein formula food | 11 | Eleva Care / ABBOTT | 0-12 months | ||
Similac / ABBOTT | |||||
EnfaGentlease/MEAD JOHNSON | |||||
优博敏佳/ SYNUTRA | |||||
舒力乐/ HANGZHOU BEINGMATE | |||||
Similac / ABBOTT | |||||
特爱敏佳/ Qingdao Shengtong | |||||
启赋®敏适/Nestle | |||||
宜品怡贝/ Yeeper Dairy | |||||
爱他美亲熠/ Nutricia | |||||
恬适康敏/Shijiazhuang Junlebao Diary Group | |||||
Lactose free formula or low lactose formula food | 15 | Beingmate / HANGZHOU BEINGMAT | 0-12 months | ||
Enfagrow / MEAD JOHNSON | |||||
安儿宁能恩/ Nestle | |||||
爱思诺赋儿嘉/ Maeil Dairies | |||||
力诺康宁/Tianjin Aumix | |||||
优博瑞安/ SYNUTRA | |||||
葆安素/Yeeper Dairy | |||||
稚舒/ Ausnutria Dairy (China) | |||||
蓓舒消/ Heilongjiang Feihe | |||||
安尼尔/ Wissun International | |||||
爱优诺优安力/ AusNuotore | |||||
特爱瑞安/ Qingdao Shengtong | |||||
嘉复褓/Zhangjiang kelubao | |||||
能盾/ Wissun International | |||||
怡安消/Shijiazhuang Junlebao Diary Group | |||||
Amino acid metabolism disorder formula food | 1 | Periflex /SHS | 0-12 months | ||
Premature or low birth weight infant formula food | 17 | Similac Neo/ABBOTT | 0-12 months | ||
Similac Gro/ABBOTT | |||||
早瑞能恩/NESTLE | |||||
Enfapro/ MEAD JOHNSON | |||||
优博安能/ SYNUTRA | |||||
Similac/ ABBOTT | |||||
Nutricia/ MILUPA | |||||
早启能恩/ Nestle | |||||
爱思诺晨而慧/ Maeil Dairies | |||||
贝新尔/ HANGZHOU BEINGMATE | |||||
Wyeth® ULTIMA® 蔼而嘉/Wyeth | |||||
甄而蔼/ Yeeper Dairy | |||||
爱优诺优健力/ AusNuotore | |||||
特爱安能/ Qingdao Shengtong | |||||
溙敏康/ Zhangjiang Kelubao | |||||
蓓舒维/Heilongjiang Feihe | |||||
蓓舒焕/Heilongjiang Feihe | |||||
托菲儿早护/Du'erbote Yili Dairy Co. LTD | |||||
托菲儿早优/Du'erbote Yili Dairy Co. LTD | |||||
Infant nutrition supplement | 5 | Similac HMFortifi/ ABBOTT | 0-12 months | ||
优博启能/ SYNUTRA | |||||
昔倍护/ HANGZHOU BEINGMATE | |||||
特爱启能/ Qingdao Shengtong | |||||
嘉璐佰/Zhejiang Kelubao | |||||
FSMP for people over the age of 12 months | Nutritionally complete foods | 56 | Pediasure / ABBOTT | 1-10 years old or above 10 | |
佳膳佳立畅/Nestle | |||||
小佰太能/Nestle | |||||
伊利®欣活®/Yili | |||||
ENSURE COMPLETE®/Abbott | |||||
NUTREN JUNIOR /Nestle | |||||
NUTREN® OPTIMUM /Nestle | |||||
优博启瑞/ SYNUTRA | |||||
力存优太®/Nantong Richen | |||||
麦孚畅清®/Jilin Maifu | |||||
爱优诺优益力/ AusNuotore | |||||
爱优诺优康力/ AusNuotore | |||||
唯卡能®/Harbin Ballansat | |||||
君蓓全/GUANGDONG JUNJOY | |||||
希瑞臻/ SUZHOU HENGRUI JIANKANG | |||||
唯源素®/YABAO | |||||
希瑞怡®/ SUZHOU HENGRUI JIANKANG | |||||
麦孚康全®/ Jilin Maifu | |||||
拜妥优/KWINS HESLTH | |||||
麦孚乐贝®/ Jilin Maifu | |||||
特爱启瑞/Qingdao Shengtong | |||||
冬泽全太/ DAISY FSMP | |||||
力存全衡素®/Nantong Richen | |||||
麦速®/ Jilin Maifu | |||||
康素得臻膳/ Ausnutria Dairy | |||||
康素得舒膳/ Ausnutria Dairy | |||||
唯源全®/ YABAO | |||||
海维舒®/ Jiangsu Zhengda Fenghai | |||||
海维安®/ Jiangsu Zhengda Fenghai | |||||
卡乐全/ Shandong Ruoyao | |||||
润能®/ HAISCO PHARMACEUTICAL | |||||
立佳营®/XI'AN LI BANG | |||||
安能®/ HAISCO PHARMACEUTICAL | |||||
麦孚乐宝®/ Jilin Maifu | |||||
立佳泰/ XI'AN LI BANG | |||||
佳安素/ AusNuotore | |||||
江中初元/ Jiangzhong Pharmaceutical | |||||
拜优能/KWINS HEALTH | |||||
辰盈/Cisen Pharmaceutical | |||||
伊盈佳®/Haizheng Sulikang | |||||
能荃力益嘉/NUTRICIA (Wuxi) | |||||
特宜元/SUNMYAN | |||||
小拜妥优/KWINS HEALTH | |||||
恒益启元/Wuxi Hengyi | |||||
恒益卓元/Wuxi Hengyi | |||||
小佳膳汇立能/Nestle(China) | |||||
冬泽全素®/ DAISY FSMP | |||||
益诺安/ Yeeper Dairy | |||||
雅培®全安素®/ Abbott (Jiaxing) | |||||
他普荟/Zhejiang kelubao | |||||
德瑞怡®/ Fresenius Kabi | |||||
德瑞太®/ Fresenius Kabi | |||||
倍舒然/Heilongjiang Feihe | |||||
博佳健®/Jilin Boya | |||||
小佳太®/ Nantong Richen | |||||
怡贯®/Linyi Shansong | |||||
冬泽益全/JIANGSU DAISY FSMP CO., LTD | |||||
佰态能/Nestlé | |||||
海维甘®/Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd. | |||||
Specific nutritionally complete foods | Tumor | 1 | 速熠素/ Nestle | Above 10 years old | |
Nutritionally incomplete foods | Electrolyte formula | 23 | 君蓓乐维/Guangdong Junyue | Above 10 years old | |
冬泽畅康/ DAISY FSMP | |||||
乐赋/ SUZHOU HENGRUI JIANKANG | |||||
特颐欣/ YICHANG HUMANWELL | |||||
葆畅佳/ CSPC Zhongnuo Yaoye | |||||
诺葆素®/Heibei Aisheng | |||||
西泓源®/Jiangshu Xihong | |||||
循康®/ HAISCO PHARMACEUTICAL | |||||
循畅®/ HAISCO PHARMACEUTICAL | |||||
辰乐维®/ Cisen Pharmaceutical | |||||
益护宁/ Zhejiang Yiyuansu | |||||
伊衡佳®/Zhejiang haizheng sulikang | |||||
艾诺利/Tibet DUOXIN | |||||
麦孚乐舒®/Jilin Maifu | |||||
金康宜®/Guizhou Jinjiu Biotech Co., Ltd | |||||
乐棠/ SUZHOU HENGRUI JIANKANG | Above 18 years old | ||||
枢能/ YICHANG HUMANWELL | |||||
若新/ Shandong Ruoyao | |||||
拜瑞恬/ KWINS HEALTH | |||||
恬能®/ Jiangsu Zhengda Fenghai | 10-14 years old | ||||
贝耶/ Shandong Ruoyao | |||||
乐潼/ SUZHOU HENGRUI JIANKANG | 1-10 years old | ||||
君蓓乐维/GUANGDONG JUNJOY | Above 1 year old | ||||
Nutrient components | 43 | 伊能佳®/ Haizheng Sulikang | Above 10 years old | ||
泉克/ Tibet DUOXIN | |||||
普柔汀®/Guanzhou EnterNutr | |||||
浦索®/ Jilin Maifu | |||||
诺葆平®/ Hebei Aisheng | |||||
葆棠华/ CSPC Zhongnuo Yaoye | |||||
益安喜®/Zhejiang Yiyuansu | |||||
西沁®/Jiangsu Xihong | |||||
冬泽定/ DAISY FSMP | |||||
蓝沛/Qingdao Languo | |||||
诺葆安®/ Hebei Aisheng | |||||
唯源泰®/ Yabao Pharmaceutical | |||||
爱优诺优达力/ AusNuotore | |||||
立如箐®/XI'AN LI BANG | |||||
初元安本®/Jiangzhong Pharmaceutical | |||||
嘉膳能/ KWINS HEALTH | |||||
若益/ Shandong Ruoyao | |||||
恒益清元/ Wuxi Hengyi | |||||
爱优诺赋力素/ AusNuotore | |||||
唯卡素®/ Harbin Ballansat | |||||
海能博/ Hangzhou New Quxing | |||||
科惠研/ Nanjing Jade Crane Ming | |||||
冬泽力太/ DAISY FSMP | |||||
若速/ Shandong Ruoyao | |||||
力优宜®/ Nantong Richen | |||||
采衡/Guangdong Yuewei | |||||
伊畅佳®/ Haizheng Sulikang | |||||
恒益舒棠/Wuxi Hengyi | |||||
咪素®/Shandong Lihao | |||||
艾诺佳/Tibet DUOXIN | |||||
君蓓清/Guangdong Junjoy | |||||
冬泽力亮/JIANGSU DAISY FSMP CO., LTD | |||||
君蓓安/ GUANGDONG JUNJOY | Above 18 years old | ||||
富安/Hainan DonglianChangfu | |||||
素乾®/ Jiangsu Zhengda Fenghai | |||||
若和®/Shandong Ruoyao | |||||
冬泽速棠/ DAISY FSMP | Above 1 year old | ||||
欣饴元/ Cisen Pharmaceutical | |||||
冬泽力安/ DAISY FSMP | |||||
冬泽予棠DAISY FSMP | |||||
麦孚卡能®/Jilin Maifu | |||||
冬泽益能/JIANGSU DAISY FSMP CO., LTD | |||||
玖康益®/Guizhou Jinjiu Biotech Co., Ltd | |||||
Thickening components | 3 | 麦孚顺宝® Jilin Maifu | Above 10 years old | ||
诺葆畅®/ Hebei Aisheng | |||||
若宁/Shandong Ruoyao FSMP Co. LTD | |||||
Liquid formula | 4 | 诺葆舒® /Heibei Aisheng | Above 10 years old | ||
术和®/ Jilin Maifu | |||||
艾诺优/Tibet DUOXIN | |||||
德瑞清®/Fresenius Kabi Huarui Pharmaceutical Co., Ltd. | |||||
Amino acid metabolism disorder formula | 2 | Periflex Ad./SHS | Above 10 years old | ||
Periflex®/SHS | 1-10 years old |
Analysis of applicants
In terms of applicants, a total of 53 companies have obtained FSMP registration certificates. Among them, 45 are domestic companies. Nestlé continues to lead with the highest number of approved products in China, totaling 16 products, followed by Jiangsu Daisy Dairy Co., LTD, and Jilin Maifu.
Nestlé, Abbott, and Nutricia, as global FSMP industry leaders, have secured approvals in both the infant and non-infant FSMP categories. In contrast, domestic companies tend to have a more singular focus. For example, domestic pharmaceutical companies mainly focus on non-infant FSMP, while domestic dairy companies primarily focus on infant FSMP. Only a few nutrition companies in the domestic market are involved in both sectors. In terms of registered companies and product numbers, the number of domestic registered companies and products has been steadily increasing, far surpassing foreign enterprises and taking a dominant position. Currently, FSMP registration is primarily concentrated among dairy, nutrition & health, and pharmaceutical companies.
Details are given in the following chart.
Figure. 6 Number of FSMP approved by companies
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