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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	國食注字TY20240001	2029.1.5
2	Heilongjiang Feihe Dairy Co., Ltd.	蓓舒維preterm/low birth weight infant formula for special medical purpose	Powder	國食注字TY20240002	2029.1.5
3	Heilongjiang Feihe Dairy Co., Ltd.	蓓舒煥preterm/low birth weight infant formula for special medical purpose	Powder	國食注字TY20240003	2029.1.5
4	Nantong Richen Bioengineering Co. LTD.	小佳太®/nutritionally complete food for special medical purposes	Powder	國食注字TY20240004	2029.1.5
5	Zhejiang Kelubao Food Co., Ltd.	嘉璐佰infant nutrition supplement for special medical purpose	Powder	國食注字TY20240005	2029.1.5
6	Wuxi Hengyi Health Technology Co., Ltd.	恒益舒棠carbohydrate formula for special medical purpose	Powder	國食注字TY20240006	2029.1.5
7	Shandong Lihao Food for Special Medical Purpose Co., Ltd.	咪素®/protein formula for special medical purpose	Powder	國食注字TY20240007	2029.1.5
8	Linyi Shansong Pharmaceutical Co., Ltd.	怡貫®/nutritionally complete food for special medical purpose	Powder	國食注字TY20240008	2029.1.5
9	Nutricia Cuijk B.V.	愛他美親熠infant partially hydrolyzed milk protein formula for special medical purpose	Powder	國食注字TY20245001	2029.1.5
10	Tibet DUOXIN HEALTH CO., LTD.	艾諾佳carbohydrate formula for special medical purpose	Powder	國食注字TY20240009	2029.2.8
11	Jilin Maifu Nutrition Technology co. LTD	麥孚卡能®carbohydrate formula for special medical purpose	Liquid	國食注字TY20240010	2029.2.8
12	Jilin Maifu Nutrition Technology co. LTD	麥孚樂舒®protein formula for special medical purpose	Liquid	國食注字TY20240011	2029.2.8
13	Hebei Aisheng Technology Co., Ltd	諾葆暢® Thickening components formula for special medical purpose	Powder	國食注字TY20240012	2029.2.8
14	Shijiazhuang Junlebao Taihang Diary Group	恬適康敏infant partially hydrolyzed milk protein formula for special medical purpose	Powder	國食注字TY20240013	2029.2.8
15	Tibet DUOXIN HEALTH CO., LTD.	艾諾優liquid formula for special medical purposes	Powder	國食注字TY20240014	2029.2.8
16	Shijiazhuang Junlebao Taihang Diary Group	怡安消lactose-free formula food for special medical purpose	Powder	國食注字TY20240015	2029.2.8
17	GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD	君蓓清protein formula for special medical purpose	Powder	國食注字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).

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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
				優博敏佳/ SYNUTRA
				NAN H.A./Nestle
				舒力樂/ HANGZHOU BEINGMATE
				Similac / ABBOTT
				特愛敏佳/ Qingdao Shengtong
				啟賦®敏適/Nestle
				宜品怡貝/ Yeeper Dairy
				愛他美親熠/ Nutricia
				恬適康敏/Shijiazhuang Junlebao Diary Group
	Lactose free formula or low lactose formula food		15	Beingmate / HANGZHOU BEINGMAT	0-12 months
				Enfagrow / MEAD JOHNSON
				安兒寧能恩/ Nestle
				愛思諾賦兒嘉/ Maeil Dairies
				力諾康寧/Tianjin Aumix
				優博瑞安/ SYNUTRA
				葆安素/Yeeper Dairy
				稚舒/ Ausnutria Dairy (China)
				蓓舒消/ Heilongjiang Feihe
				安尼爾/ Wissun International
				愛優諾優安力/ AusNuotore
				特愛瑞安/ Qingdao Shengtong
				嘉復褓/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
				優博安能/ SYNUTRA
				Similac/ ABBOTT
				Nutricia/ MILUPA
				早啟能恩/ Nestle
				愛思諾晨而慧/ Maeil Dairies
				貝新爾/ HANGZHOU BEINGMATE
				Wyeth® ULTIMA® 藹而嘉/Wyeth
				甄而藹/ Yeeper Dairy
				愛優諾優健力/ AusNuotore
				特愛安能/ Qingdao Shengtong
				溙敏康/ Zhangjiang Kelubao
				蓓舒維/Heilongjiang Feihe
				蓓舒煥/Heilongjiang Feihe
	Infant nutrition supplement		5	Similac HMFortifi/ ABBOTT	0-12 months
				優博啟能/ SYNUTRA
				昔倍護/ HANGZHOU BEINGMATE
				特愛啟能/ 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
				佳膳佳立暢/Nestle
				小佰太能/Nestle
				伊利®欣活®/Yili
				ENSURE COMPLETE®/Abbott
				NUTREN JUNIOR /Nestle
				NUTREN® OPTIMUM /Nestle
				優博啟瑞/ SYNUTRA
				力存優太®/Nantong Richen
				麥孚暢清®/Jilin Maifu
				愛優諾優益力/ AusNuotore
				愛優諾優康力/ 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
				麥孚康全®/ Jilin Maifu
				拜妥優/KWINS HESLTH
				麥孚樂貝®/ Jilin Maifu
				特愛啟瑞/Qingdao Shengtong
				冬澤全太/ DAISY FSMP
				力存全衡素®/Nantong Richen
				麥速®/ Jilin Maifu
				康素得臻膳/ Ausnutria Dairy
				康素得舒膳/ Ausnutria Dairy
				唯源全®/ YABAO
				海維舒®/ Jiangsu Zhengda Fenghai
				海維安®/ Jiangsu Zhengda Fenghai
				卡樂全/ Shandong Ruoyao
				潤能®/ HAISCO PHARMACEUTICAL
				立佳營®/XI'AN LI BANG
				安能®/ HAISCO PHARMACEUTICAL
				麥孚樂寶®/ Jilin Maifu
				立佳泰/ XI'AN LI BANG
				佳安素/ AusNuotore
				江中初元/ Jiangzhong Pharmaceutical
				拜優能/KWINS HEALTH
				辰盈/Cisen Pharmaceutical
				伊盈佳®/Haizheng Sulikang
				能荃力益嘉/NUTRICIA （Wuxi）
				特宜元/SUNMYAN
				小拜妥優/KWINS HEALTH
				恒益啟元/Wuxi Hengyi
				恒益卓元/Wuxi Hengyi
				小佳膳匯立能/Nestle(China)
				冬澤全素®/ DAISY FSMP
				益諾安/ Yeeper Dairy
				雅培®全安素®/ Abbott (Jiaxing)
				他普薈/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
				怡貫®/Linyi Shansong
	Specific nutritionally complete foods	Tumor	1	速熠素/ Nestle	Above 10 years old
	Nutritionally incomplete foods	Electrolyte formula	23	君蓓樂維/Guangdong Junyue	Above 10 years old
				冬澤暢康/ DAISY FSMP
				樂賦/ SUZHOU HENGRUI JIANKANG
				特頤欣/ YICHANG HUMANWELL
				葆暢佳/ CSPC Zhongnuo Yaoye
				諾葆素®/Heibei Aisheng
				西泓源®/Jiangshu Xihong
循康®/ HAISCO PHARMACEUTICAL
循暢®/ HAISCO PHARMACEUTICAL
辰樂維®/ Cisen Pharmaceutical
益護寧/ Zhejiang Yiyuansu
伊衡佳®/Zhejiang haizheng sulikang
艾諾利/Tibet DUOXIN
麥孚樂舒®/Jilin Maifu
樂棠/ SUZHOU HENGRUI JIANKANG				Above 18 years old
樞能/ YICHANG HUMANWELL
若新/ Shandong Ruoyao
拜瑞恬/ KWINS HEALTH
恬能®/ Jiangsu Zhengda Fenghai				10-14 years old
貝耶/ Shandong Ruoyao				10-14 years old
樂潼/ SUZHOU HENGRUI JIANKANG				1-10 years old
君蓓樂維/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
			諾葆平®/ Hebei Aisheng
			葆棠華/ CSPC Zhongnuo Yaoye
			益安喜®/Zhejiang Yiyuansu
			西沁®/Jiangsu Xihong
			冬澤定/ DAISY FSMP
			藍沛/Qingdao Languo
			諾葆安®/ Hebei Aisheng
			唯源泰®/ Yabao Pharmaceutical
			愛優諾優達力/ 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
			愛優諾賦力素/ AusNuotore
			唯卡素®/ Harbin Ballansat
			海能博/ Hangzhou New Quxing
			科惠研/ Nanjing Jade Crane Ming
			冬澤力太/ DAISY FSMP
			若速/ Shandong Ruoyao
			力優宜®/ Nantong Richen
			采衡/Guangdong Yuewei
			伊暢佳®/ Haizheng Sulikang
			恒益舒棠/Wuxi Hengyi
			咪素®/Shandong Lihao
			艾諾佳/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
			冬澤速棠/ DAISY FSMP	Above 1 year old
			欣飴元/ Cisen Pharmaceutical
			冬澤力安/ DAISY FSMP
			冬澤予棠DAISY FSMP
			麥孚卡能®/Jilin Maifu
Thickening components		2	麥孚順寶® Jilin Maifu	Above 10 years old
Thickening components		2	諾葆暢®/ Hebei Aisheng	Above 10 years old
Liquid formula	3	諾葆舒® /Heibei Aisheng	Above 10 years old
		術和®/ Jilin Maifu
		艾諾優/Tibet DUOXIN
Amino acid metabolism disorder formula	2	Periflex Ad./SHS	Above 10 years old
Amino acid metabolism disorder formula	2	Periflex®/SHS	Above 10 years old

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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Further Information

【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 1)

【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 2)

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【FSMP】 17 FSMP Approved in the First Quarter of 2024, Bringing the Total to 181

FSMP registration and approval status

Analysis of registered FSMP Types

Distribution of approved product types

Analysis of applying companies