Up to October, 11 New FSMP Products have been Approved for Use in 2022 –Bringing the Total to 92 Approved Products - Regulatory News - Food & Food Contact Materials

Updated on 27 October 2022

According to information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 92.

Companies must register FSMP products with the SAMR. This applies to both imported products as well as those produced domestically and marketed in China.

In 2022, fat formula and specific nutritionally complete food were both approved for the first time, greatly enriching the FSMP categories approved for use in China. According to the statistics, eleven products have been approved since January 2022. Some of the registered companies even successfully received approval for more than one FSMP products

Summary and Analysis of the FSMP Approved for Use in China

At present, a total of 92 FSMP products have been approved in China, including 63 domestic products and 29 foreign products. Among the 92 approved products, 70 products are powders, and 22 products are liquid.

The following product types have been approved:

38 are infant formulas for special medical purposes;
30 are nutritionally incomplete food;
23 are nutritionally complete food; and
1 is a specific nutritionally complete food.

Note: Please refer to the appendix at the bottom of this article for details on the name, registered enterprise, registration number, validity period, and other information of the 92 products (the information is taken from the SAMR’s website.

Figure 1. Different categories of approved products

Relevant information is listed as below in table 1:

Table 1. Summary of the categories/types of the approved products

Categories/types			Amount approved	Product/Company	Intended age group
FSMP for infants under the age of 12 months	Extensively hydrolyzed milk protein formula or amino acid-based formula food		4	Neocate / SHS	0-12 months
				ALFARE/ NESTLE
				Althera/NESTLE
				ALFAMINO/ NESTLE
	Partially hydrolyzed milk protein formula food		6	Eleva Care / ABBOTT	0-12 months
				Similac / ABBOTT
				EnfaGentlease / MEAD JOHNSON
				优博敏佳/ SYNUTRA
				NAN H.A./Nestle
				舒力乐/ HANGZHOU
				Similac / ABBOTT
	Lactose free formula or low lactose formula food		11	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
	Amino acid metabolism disorder formula food		1	Periflex / SHS	0-12 months
	Premature or low birth weight infant formula food		13	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
	Infant nutrition supplement		4	Similac HMFortifi/ ABBOTT	0-12 months
				优博启能/ SYNUTRA
				昔倍护/ HANGZHOU BEINGMATE
				特爱启能/ Qingdao Shengtong
FSMP for people over the age of 12 months	Nutritionally complete foods		23	Pediasure / ABBOTT	1-10 year-old or above 10 years old
				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
	Specific nutritionally complete foods	Tumor	1	速熠素/ Nestle	Above 10 year-old
	Nutritionally incomplete foods	Electrolyte formula	13	乐赋/ SUZHOU HENGRUI JIANKANG	Above 10 year-old
				乐棠/ SUZHOU HENGRUI JIANKANG	Above 18 year-old
				艾诺利/Tibet DUOXIN	Above 10 year-old
				恬能®/ Jiangsu Zhengda Fenghai	10-14 year-old
				乐潼/ SUZHOU HENGRUI JIANKANG	1-10 year-old
				君蓓乐维/GUANGDONG JUNJOY	Above 1 year-old
				枢能/ YICHANG HUMANWELL	Above 18 year-old
				若新/ Shandong Ruoyao	Above 18 year-old
				卡捷®/ Jilin Maifu	Above 10 year-old
				贝耶/ Shandong Ruoyao	10-14 year-old
				特颐欣/ YICHANG HUMANWELL	Above 10 year-old
				葆畅佳/ CSPC Zhongnuo Yaoye	Above 10 year-old
				冬泽畅康/ DAISY FSMP	Above 10 year-old
		Nutrient components	14	伊能佳®/Zhejiang海正甦力康	Above 10 year-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/Hunan Jiudian
				蓝沛/Qingdao Languo
				君蓓安/ GUANGDONG JUNJOY	Above 18 year-old
				富安/Hainan DonglianChangfu
				素乾®/ Jiangsu Zhengda Fenghai
				冬泽速棠/ DAISY FSMP	Above 1 year-old
		Thickening components	0	NA	NA
		Liquid formula	0	NA	NA
		Amino acid metabolism disorder formula	2	Periflex Ad./SHS	Above 10 year-old
		Amino acid metabolism disorder formula	2	Periflex®/SHS	Above 10 year-old

A total of 38 companies have obtained FSMP registration certificates, 31 of which are domestic companies. Among the 92 products, 12 have been developed by Nestle including the first specific nutritionally complete food. This is the largest number of registrations by an individual company, followed by 8 registrations by Abbot Laboratories. In addition, Nestle, Abbott and NUTRICIA, as the world's leading FSMP enterprises, have diversified products.

Although only 11 products from eight companies were approved in 2022, three of them are new companies. One company successfully registered three products. In the future, the FSMP market is expected to attract more investment from a wider variety of companies. In the future, the FSMP market is expected to attract more investment from a wider variety of companies.

The information for each enterprise to register FSMP is as follows:

China,Food,FSMP,Registration,Analysis,Medical,Special

Figure 2. Quantity of approved FSMP products by different companies

Registration for the FSMP products began in 2017. In the beginning, FSMP products for infants under the age of 12 months accounted for the highest proportion of registrations.

The registration of FSMP products for infants under the age of 12 months was mainly concentrated in 2018 and 2019, while the registration of nutritionally incomplete food was concentrated in 2021.

So far in 2022, there is no clear product category that is outperforming the others, but this year has seen the first registration of a product in the specific nutritionally complete product category, , which is great progress for the FSMP market.

The trend of registration types of the FSMP over the years is as follows:

Figure 3. Trend chart of FSMP registration types over the years

The above information is analysis associated with the current situation of FSMP registration in China. Click to know more about FSMP registration requirements in China.

Annex 1. Detailed information of the 92 approved FSMP products

Table 2. The 92 approved FSMP products

S.N.	Applicant	Product name	Dosage form	Certificate number	Expiry date
1	SHS INTERNATIONAL LTD	Neocate infant amino acid formula (powder) for special medical purpose	Powder	国食注字TY20175001	2022.11.19
2	ABBOTT LABORATORIES S.A.	Similac infant partially hydrolyzed milk protein formula (powder) for special medical purpose	Powder	国食注字TY20175002	2022.11.19
3	ABBOTT LABORATORIES S.A.	Eleva Care infant partially hydrolyzed milk protein formula (powder) for special medical purpose	Powder	国食注字TY20175003	2022.11.19
4	HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.	Beingmate infant lactose free formula for special medical purpose	Powder	国食注字TY20180001	2023.2.12
5	SHS INTERNATIONAL LTD	Periflex infant phenylketonuria formula (powder) for special medical purpose	Powder	国食注字TY20185001	2023.2.26
6	MEAD JOHNSON B.V.	EnfaGentlease infant partially hydrolyzed milk protein formula (powder) for special medical purpose	Powder	国食注字TY20185002	2023.3.19
7	ABBOTT NUTRITION, ABBOTT LABORATORIES	Similac Neo preterm/low birth weight infant formula for special medical purpose	Liquid	国食注字TY20185003	2023.6.25
8	ABBOTT NUTRITION, ABBOTT LABORATORIES	Similac Gro preterm/low birth weight infant formula for special medical purpose	Liquid	国食注字TY20185004	2023.6.25
9	MEAD JOHNSON B.V.	Enfagrow infant lactose free formula (powder) for special medical purpose	Powder	国食注字TY20185005	2023.7.22
10	NESTLE NEDERLAND B.V.	早瑞能恩 preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20185006	2023.7.22
11	SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	乐赋 electrolyte formula for special medical purpose	Liquid	国食注字TY20180002	2023.7.22
12	SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	乐棠electrolyte formula for special medical purpose	Liquid	国食注字TY20180003	2023.7.22
13	ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED	Pediasure nutritionally complete food for special medical purpose	Powder	国食注字TY20185007	2023.8.2
14	MEAD JOHNSON B.V.	Enfapro preterm/low birth weight infant formula (powder) for special medical purpose	Powder	国食注字TY20185008	2023.8.13
15	SYNUTRA INTERNATIONAL INC	优博敏佳partially hydrolyzed milk protein formula for special medical purpose	Powder	国食注字TY20180004	2023.8.13
16	SYNUTRA INTERNATIONAL INC	优博安能preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20180005	2023.8.13
17	ABBOTT LABORATORIES S.A.	ABBOTT Similac preterm/low birth weight infant formula (powder) for special medical purpose	Powder	国食注字TY20185009	2023.10.7
18	MILUPA GMBH	Nutricia preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20185010	2023.10.7
19	SHS INTERNATIONAL LTD	Periflex Ad. phenylketonuria formula (powder) for special medical purpose	Powder	国食注字TY20185011	2023.12.19
20	NESTLE NEDERLAND B.V.	ALFARE infant extensively hydrolyzed milk protein formula for special medical purpose	Powder	国食注字TY20185012	2023.12.19
21	ABBOTT NUTRITION	Similac HMFortifi infant nutrition supplement for special medical purpose	Powder	国食注字TY20185013	2023.12.19
22	Nestlé Deutschland AG	早启能恩 preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20195001	2024.01.23
23	Nestlé Deutschland AG	NAN H.A. partially hydrolyzed milk protein formula for special medical purpose	Powder	国食注字TY20195002	2024.01.23
24	NESTLE NEDERLAND B.V.	安儿宁能恩 infant lactose free formula for special medical purpose	Powder	国食注字TY20195003	2024.01.23
25	Nestle Health Science China	佳膳佳立畅nutritionally complete food for special medical purpose	Liquid	国食注字TY20190001	2024.6.10
26	SYNUTRA INTERNATIONAL INC	优博启能infant nutrition supplement for special medical purpose	Powder	国食注字TY20190002	2024.6.13
27	Nestlé Suisse SA, factory Konolfingen	PEPTAMEN JUNIOR nutritionally complete food for special medical purpose	Powder	国食注字TY20195004	2024.6.13
28	Du’erbote Yili Dairy Co. LTD	伊利®欣活® nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20190003	2024.6.18
29	HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.	贝新尔preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20190004	2024.6.18
30	ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED	ENSURE COMPLETE® nutritionally complete food for special medical purpose	Powder	国食注字TY20195005	2024.6.26
31	Nestlé Suisse SA, factory Konolfingen	NUTREN JUNIOR nutritionally complete food for special medical purpose	Powder	国食注字TY20195006	2024.6.26
32	Nestlé Suisse SA, factory Konolfingen	NUTREN OPTIMUM nutritionally complete food for special medical purpose	Powder	国食注字TY20195007	2024.6.26
33	Maeil Dairies Co., Ltd	爱思诺赋儿嘉infant lactose free formula for special medical purpose	Powder	国食注字TY20195009	2024.6.27
34	Maeil Dairies Co., Ltd	爱思诺晨而慧preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20195008	2024.6.27
35	HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.	昔倍护infant nutrition supplement for special medical purpose	Powder	国食注字TY20190005	2024.7.29
36	Tianjin Aumix Dairy Co. LTD	力诺康宁infant lactose free formula for special medical purpose	Powder	国食注字TY20190006	2024.10.13
37	SYNUTRA INTERNATIONAL INC	优博启瑞nutritionally complete food for special medical purpose	Powder	国食注字TY20190008	2024.10.21
38	Nantong Richen Bioengineering Co. LTD	力存优太nutritionally complete food for special medical purpose	Powder	国食注字TY20190007	2024.10.21
39	Nestle Nederland B.V.	Althera infant extensively hydrolyzed milk protein formula for special medical purpose	Powder	国食注字TY20195010	2024.10.21
40	Wyeth Nutritionals Ireland Ltd.	Wyeth® ULTIMA® 蔼而嘉preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20195011	2024.10.29
41	SYNUTRA INTERNATIONAL INC	优博瑞安infant lactose free formula for special medical purpose	Powder	国食注字TY20190009	2024.11.24
42	Jilin Maifu Nutrition Technology co. LTD Changchun Branch	麦孚畅清® nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20190010	2024.12.11
43	SHS International Ltd	Periflex® amino acid metabolism disorder formula for special medical purpose	Powder	国食注字TY20195012	2024.12.24
44	AusNuotore	爱优诺优益力 nutritionally complete food for special medical purpose	Powder	国食注字TY20200001	2025.2.27
45	AusNuotore	爱优诺优康力 nutritionally complete food for special medical purpose	Powder	国食注字TY20200002	2025.2.27
46	Harbin Ballansat Clinical Nutrition Co., Ltd	唯卡能® nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20200003	2025.3.23
47	GUANGDONG JUNJOY MEDICAL NUTRITION CO., LTD	君蓓全 nutritionally complete food for special medical purpose	Powder	国食注字TY20200004	2025.3.27
48	SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	希瑞臻nutritionally complete food for special medical purpose	Powder	国食注字TY20200005	2025.4.21
49	HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.	舒力乐 infant partially hydrolyzed milk protein formula for special medical purpose	Powder	国食注字TY20200006	2025.5.13
50	YABAO Pharmaceutical Group Co., Ltd	唯源素® nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20200007	2025.5.13
51	Nestle Nederland B.V.	ALFAMINO infant amino acid formula for special medical purpose	Powder	国食注字TY20205001	2025.5.15
52	Tibet DUOXIN HEALTH CO., LTD.	艾诺利Electrolyte formula for special medical purposes	Liquid	国食注字TY20200008	2025.8.9
53	Zhejiang 海正甦力康Biotechnology Co. LTD	伊能佳® protein formula for special medical purpose	Powder	国食注字TY20200009	2025.8.27
54	Tibet DUOXIN HEALTH CO., LTD.	泉克 carbohydrate formula for special medical purpose	Liquid	国食注字TY20200010	2025.8.27
55	SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	希瑞怡® nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20200011	2025.9.28
56	Guangzhou EnterNutr	普柔汀®protein formula for special medical purpose	Powder	国食注字TY20200012	2025.10.27
57	Jilin Maifu Nutrition Technology co. LTD Changchun Branch	浦索®protein formula (powder) for special medical purpose	Powder	国食注字TY20200013	2025.12.20
58	Jilin Maifu Nutrition Technology co. LTD Changchun Branch	麦孚康全®nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20210001	2026.1.19
59	Beian Yeeper Dairy Co., Ltd	葆安素infant lactose free formula for special medical purpose	Powder	国食注字TY20210002	2026.4.11
60	Beian Yeeper Dairy Co., Ltd	甄而蔼low birth weight infant formula for special medical purpose	Powder	国食注字TY20210003	2026.4.11
61	Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd	恬能®Electrolyte formula for special medical purposes	Liquid	国食注字TY20210004	2026.4.11
62	Ausnutria Dairy (China) Co., Ltd	稚舒infant lactose free formula for special medical purpose	Powder	国食注字TY20210005	2026.4.11
63	SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD	乐潼Electrolyte formula for special medical purposes	Liquid	国食注字TY20210006	2026.4.11
64	GUANGDONG JUNJOY MEDICAL NUTRITION CO. LTD	君蓓安carbohydrate formula for special medical purpose	Liquid	国食注字TY20210007	2026.4.11
65	Heilongjiang Feihe Dairy Co., Ltd	蓓舒消infant lactose free formula for special medical purpose	Powder	国食注字TY20210008	2026.4.11
66	Wissun International Nutrition Group Co., Ltd	安尼尔infant lactose free formula for special medical purpose	Powder	国食注字TY20210009	2026.4.11
67	Hainan DonglianChangfu Pharmaceutical Co., Ltd	富安特carbohydrate formula for special medical purpose	Liquid	国食注字TY20210010	2026.4.11
68	Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd	素乾® carbohydrate formula for special medical purpose	Liquid	国食注字TY20210011	2026.4.11
69	GUANGDONG JUNJOY MEDICAL NUTRITION CO. LTD	君蓓乐维Electrolyte formula for special medical purposes	Liquid	国食注字TY20210012	2026.4.11
70	JIANGSU DAISY FSMP CO., LTD	冬泽速棠carbohydrate formula for special medical purpose	Powder	国食注字TY20210013	2026.4.11
71	Hebei Aisheng Technology Co., Ltd	诺葆平® protein formula for special medical purpose	Powder	国食注字TY20210014	2026.4.11
72	KWINS HEALTHY Pharmaceutical Jiangsu Co., LTD	拜妥优nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20210015	2026.6.6
73	YICHANG HUMANWELL FSMP Co. LTD	枢能Electrolyte formula for special medical purposes	Liquid	国食注字TY20210016	2026.8.17
74	CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD	葆棠华carbohydrate formula for special medical purpose	Liquid	国食注字TY20210017	2026.8.17
75	Shandong Ruoyao FSMP Co. LTD	若新Electrolyte formula for special medical purposes	Powder	国食注字TY20210018	2026.8.17
76	Jilin Maifu Nutrition Technology co. LTD Changchun Branch	麦孚乐贝®nutritionally complete food (powder) for special medical purpose	Powder	国食注字TY20210019	2026.8.17
77	Zhejiang Yielement Food Co. LTD	益安喜®carbohydrate formula for special medical purpose	Liquid	国食注字TY20210020	2026.8.17
78	Jilin Maifu Nutrition Technology co. LTD Changchun Branch	卡捷®Electrolyte formula for special medical purposes	Powder	国食注字TY20210021	2026.8.17
79	Shandong Ruoyao FSMP Co. LTD	贝耶Electrolyte formula for special medical purposes	Liquid	国食注字TY20210022	2026.11.11
80	YICHANG HUMANWELL FSMP Co. LTD	特颐欣Electrolyte formula for special medical purposes	Liquid	国食注字TY20210023	2026.11.11
81	Jiangsu Xihong Biological Medicine Co. LTD	西沁® carbohydrate formula for special medical purpose	Liquid	国食注字TY20210024	2026.11.11
82	Qingdao Lanpei Nutrition health Technology Co., LTD	蓝沛fat formula for special medical purpose	Powder	国食注字TY20220001	2027.04.05
83	Hunan Jiudian Pharmaceutical Co. LTD	冬泽定protein formula for special medical purpose	Powder	国食注字TY20220002	2027.04.05
84	AusNuotore	爱优诺优安力infant lactose free formula for special medical purpose	Powder	国食注字TY20220003	2027.06.16
85	Nestle Nederland B.V.	速熠素nutritionally complete food for special medical purpose of tumor	Liquid	国食注字TY20220004	2027.06.16
86	Qingdao Shengtong Nutrition Food Co., LTD	特爱启瑞nutritionally complete food for special medical purpose	Powder	国食注字TY20220005	2027.08.16
87	Qingdao Shengtong Nutrition Food Co., LTD	特爱启能infant nutrition supplement for special medical purpose	Powder	国食注字TY20220006	2027.08.16
88	CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD	葆畅佳Electrolyte formula for special medical purposes	Liquid	国食注字TY20220007	2027.08.16
89	JIANGSU DAISY FSMP CO., LTD	冬泽全太nutritionally complete food for special medical purpose	Powder	国食注字TY20220008	2027.10.13
90	AusNuotore	爱优诺优健力preterm/low birth weight infant formula for special medical purpose	Powder	国食注字TY20220009	2027.10.13
91	Nantong Richen Bioengineering Co. LTD	力存全衡素®nutritionally complete food for special medical purpose	Powder	国食注字TY20220010	2027.10.13
92	JIANGSU DAISY FSMP CO., LTD	冬泽畅康Electrolyte formula for special medical purposes	Liquid	国食注字TY20220011	2027.10.13

Note: 1. the general names in the table are updated according to the Notice on the Adjustment of General Name of FSMP

2. "舒乐加" (SUZHOU HENGRUI JIANKANG) changed its name to "乐赋" on August 23, 2019;YILI “焕初” changed its name to“伊利®欣活®”on December 31, 2019

3. “澳优”(Ausnutria Dairy) changed its name to “稚舒” on December 28, 2021.

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