Updated on April 9, 2024
According to the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) approved in China has reached 181. 17 FSMPs have been approved in the first quarter of 2024, including 16 domestic products and 1 imported. These include 3 domestic nutritionally complete products, 8 domestic nutritionally incomplete products, 5 domestic infant formula for special medical purposes, and 1 imported infant formula for special medical purposes. Details are as follows:
Table 1. List of newly approved FSMP products
S.N. | Applicant | Product name | Dosage form | Certificate number | Expiry date |
1 | Jilin Boya Nutraceuticals Co., Ltd. | 博佳健® nutritionally complete food for special medical purposes | Powder | 国食注字TY20240001 | 2029.1.5 |
2 | Heilongjiang Feihe Dairy Co., Ltd. | 蓓舒维preterm/low birth weight infant formula for special medical purpose | Powder | 国食注字TY20240002 | 2029.1.5 |
3 | Heilongjiang Feihe Dairy Co., Ltd. | 蓓舒焕preterm/low birth weight infant formula for special medical purpose | Powder | 国食注字TY20240003 | 2029.1.5 |
4 | Nantong Richen Bioengineering Co. LTD. | 小佳太®/nutritionally complete food for special medical purposes | Powder | 国食注字TY20240004 | 2029.1.5 |
5 | Zhejiang Kelubao Food Co., Ltd. | 嘉璐佰infant nutrition supplement for special medical purpose | Powder | 国食注字TY20240005 | 2029.1.5 |
6 | Wuxi Hengyi Health Technology Co., Ltd. | 恒益舒棠carbohydrate formula for special medical purpose | Powder | 国食注字TY20240006 | 2029.1.5 |
7 | Shandong Lihao Food for Special Medical Purpose Co., Ltd. | 咪素®/protein formula for special medical purpose | Powder | 国食注字TY20240007 | 2029.1.5 |
8 | Linyi Shansong Pharmaceutical Co., Ltd. | 怡贯®/nutritionally complete food for special medical purpose | Powder | 国食注字TY20240008 | 2029.1.5 |
9 | Nutricia Cuijk B.V. | 爱他美亲熠infant partially hydrolyzed milk protein formula for special medical purpose | Powder | 国食注字TY20245001 | 2029.1.5 |
10 | Tibet DUOXIN HEALTH CO., LTD. | 艾诺佳carbohydrate formula for special medical purpose | Powder | 国食注字TY20240009 | 2029.2.8 |
11 | Jilin Maifu Nutrition Technology co. LTD | 麦孚卡能®carbohydrate formula for special medical purpose | Liquid | 国食注字TY20240010 | 2029.2.8 |
12 | Jilin Maifu Nutrition Technology co. LTD | 麦孚乐舒®protein formula for special medical purpose | Liquid | 国食注字TY20240011 | 2029.2.8 |
13 | Hebei Aisheng Technology Co., Ltd | 诺葆畅® Thickening components formula for special medical purpose | Powder | 国食注字TY20240012 | 2029.2.8 |
14 | Shijiazhuang Junlebao Taihang Diary Group | 恬适康敏infant partially hydrolyzed milk protein formula for special medical purpose | Powder | 国食注字TY20240013 | 2029.2.8 |
15 | Tibet DUOXIN HEALTH CO., LTD. | 艾诺优liquid formula for special medical purposes | Powder | 国食注字TY20240014 | 2029.2.8 |
16 | Shijiazhuang Junlebao Taihang Diary Group | 怡安消lactose-free formula food for special medical purpose | Powder | 国食注字TY20240015 | 2029.2.8 |
17 | GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD | 君蓓清protein formula for special medical purpose | Powder | 国食注字TY20240016 | 2029.2.8 |
FSMP registration and approval status
As of April 1, 2024, a total of 181 FSMPs have obtained approval. Of these, 148 are domestically produced, while 33 are imported. Notably, among the 181 approved products, powdered formulations predominate, with 137 being powdered, whereas the remaining 44 are in liquid form.
Analysis of registered FSMP Types
Since the successful registration of the first infant formula for special medical purposes in 2017, the pathway for registering FSMP has officially opened. As shown in Figure 3, it initially saw high registrations followed by a decline, with registrations predominantly concentrated in 2018 and 2019. On the other hand, registrations for nutritionally incomplete formulas were focused in 2021 and 2023. In 2022, although the overall registration was relatively low, there was an increase in the variety of registered products, including the first specific nutritionally complete formula food. In 2023, the first thickening module was introduced, and registrations mainly centered around both nutritionally complete and incomplete products, accounting for as much as 87%. Compared to the registration volume in 2022, there was a significant surge in registrations in 2023. By the first quarter of 2024, 17 new products have been added, indicating a strong momentum, with specific nutritionally complete foods still requiring further breakthroughs.
Detailed FSMP registration types over the years are illustrated in the figure below.
Fig. 3 FSMP registration over the years
Distribution of approved product types
In terms of product types, as shown in the following chart, among the approved products, 54 are infant formula foods for special medical purposes, accounting for 30% of the total. This includes 5 deep hydrolyzed protein or amino acid formulas, 11 partially hydrolyzed protein formulas, 15 lactose-free or low-lactose formulas, 1 amino acid metabolic disorder formula, 17 premature/low birth weight infant formulas, and 5 nutritional supplements. Additionally, there are 70 nutritionally incomplete formula foods, including 21 protein modules, 1 fat module, 18 carbohydrate modules, 23 electrolyte formulas, 2 thickening modules, 3 liquid formulas, and 2 amino acid metabolic disorder formulas (for ages 1 and above), accounting for 39% of the total. Furthermore, there are 56 nutritionally complete formula foods, representing 32% of the total, including 9 and 47 nutritionally complete formula foods for age 1-10, and age 1 and above, respectively. There is only 1 specific nutritionally complete formula food - 速熠素 tumor nutritionally complete formula food special medical purpose.
Note: For detailed information on the names, registering companies, registration numbers, and expiration dates, please click here to check out the latest list of registered FSMP products (official approval information is subject to updates on the official website).
Fig. 4 Distribution of product types
Fig. 5 Registration counts by product category
Details are as follows:
Table 2. FSMP product types and approval status
Categories/types | Approval counts | Product/Company | Targeted population | ||
---|---|---|---|---|---|
Infant formula foods for special medical purposes | 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 | |||||
NAN H.A./Nestle | |||||
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 | |||||
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 | |||||
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 | |||||
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 | 40 | 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 | |||||
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 | |||||
Thickening components | 2 | 麦孚顺宝® Jilin Maifu | Above 10 years old | ||
诺葆畅®/ Hebei Aisheng | |||||
Liquid formula | 3 | 诺葆舒® /Heibei Aisheng | Above 10 years old | ||
术和®/ Jilin Maifu | |||||
艾诺优/Tibet DUOXIN | |||||
Amino acid metabolism disorder formula | 2 | Periflex Ad./SHS | Above 10 years old | ||
Periflex®/SHS |
Analysis of applying companies
In terms of applicants, a total of 52 companies have obtained FSMP registrations. Among these, 44 are domestic companies holding registration certificates. Nestlé continues to lead with the highest number of approved products in China, totaling 15 products, followed by Jilin Maifu. Global industry leaders like Nestlé, Abbott, and Nutricia have secured approvals for products in both non-infant and infant FSMP categories. Meanwhile, domestic companies exhibit a trend towards product specialization. Domestic pharmaceutical companies primarily focus on non-infant FSMP, whereas domestic dairy companies concentrate on infant FSMP. Only a few companies are involved in both infant and non-infant FSMP sectors. In terms of the number of registered companies and products, domestic companies have surpassed foreign counterparts and now dominate the market Currently, FSMP registrations are predominantly held by dairy, nutrition, and pharmaceutical companies.
Details are illustrated in the following chart.
Fig.6 Number of FSMP approved by companies
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