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Updated on 13 Jan. 2022
Based on the relevant information released from the State Administration for Market Regulation (SAMR), the approved FSMP products in China have reached 81 until now. In 2021, the number of newly registered FSMS reached 24,nutritionally incomplete food accounts for two-thirds of the 24 products and a total of 16 non-whole nutrition formula foods, including electrolyte formula, carbohydrate component and protein component, were registered. The details are as follows.
Summary and Analysis of the Approved FSMP in China
Until now, totally 81 FSMP products have been approved in China, including 52 domestic products and 29 foreign products. Among the 81 approved products, the dosage forms of 62 products are powder, and only 19 products are liquid.
In terms of product type, as shown in the figure below, 36 of them are infant formula for special medical purposes, 25 are nutritionally incomplete food, and 20 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.
Note: Please refer to the appendix at the bottom of this article for details of the name, registered enterprise, registration number, validity period and other information of the 81 products.
Figure 1. The approved products in different categories
Relevant information are listed as below in table 1:
Table 1. Summary of the categories/types of the approved products
Categories/types | Amount being approved | Product/Company | Adapted population | ||
|---|---|---|---|---|---|
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 | 10 | 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 | |||||
澳优/ Ausnutria Dairy (China) | |||||
蓓舒消/ Heilongjiang Feihe | |||||
安尼尔/ Wissun International | |||||
Amino acid metabolism disorder formula food | 1 | Periflex / SHS | 0-12 months | ||
Premature or low birth weight infant formula food | 12 | 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 | |||||
Infant nutrition supplement | 3 | Similac HMFortifi/ ABBOTT | 0-12 months | ||
优博启能/ SYNUTRA | |||||
昔倍护/ HANGZHOU BEINGMATE | |||||
FSMP for people over the age of 12 months | Nutritionally complete foods | 20 | 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 | |||||
Specific nutritionally complete foods | 0 | NA | NA | ||
Nutritionally incomplete foods | Electrolyte formula | 11 | 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 | ||||
Nutrient components | 12 | 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®/浙江益元素 | |||||
西沁®/江苏希宏 | |||||
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 | ||
Periflex®/SHS | |||||
There are totally 35 companies obtaining FSMP registration certificates, while among the 81 products, 11 of them have been developed by one company – Nestle. Moreover, there are 28 domestic companies obtaining FSMP certificate in China.
The information for each enterprise to register FSMP is as follows.
Figure 2. Quantity of approved FSMP products at different companies
The Registration of FSMP in China began in 2017. At the beginning, FSMP for infants under the age of 12 months accounted for a high proportion of registration, due to the strong R&D background of infant formula food enterprises. The proportion of nutritionally incomplete foods reached 67% in 2021, which was much higher than other types of FSMP. At present, the categories of the FSMP products in China still need to be enriched.
The trend of registration types of the FSMP over the years is as follow:
Figure 3. Trend chart of FSMP registration types over the years
The above information are 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 81 approved FSMP products
Table 2. The 81 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 | 澳优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®特殊医学用途碳水化合物组件配方食品 | Liquid | 国食注字TY20210024 | 2026.11.11 |
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
If you have any needs or questions, please contact us at service@cirs-group.com.
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