Updated on September 21, 2023
According to the 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 140.
Companies must register FSMP products with the SAMR, and it is applicable to both foreign and domestic products sold in China. As of September 20, 46 new FSMP Products have been approved for use in 2023, covering 23 nutritionally complete foods, 18 nutritionally incomplete foods, and five infant formulas for special medical purposes.
Summary and Analysis of the FSMP Approved for Use in China
At present, a total of 140 FSMP products have been approved in China, including 109 domestic products and 31 foreign products. Among the 140 approved products, 103 products are powder, and 37 products are liquid.
The following product types have been approved:
- 43 infant formulas for special medical purposes;
- 50 nutritionally incomplete food;
- 46 nutritionally complete food;
- one is a specific nutritionally complete food.
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 140 products (the information is from the SAMR’s website).
Figure 1. Different categories of approved products
Relevant information is listed below in table 1:
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 |
5 |
Neocate / SHS |
0-12 months |
|
ALFARE/ NESTLE |
|||||
Althera/NESTLE |
|||||
ALFAMINO/ NESTLE |
|||||
Pepti Junior/Nutricia |
|||||
Partially hydrolyzed milk protein formula food |
8 |
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 |
|||||
Lactose-free formula or low-lactose formula food |
12 |
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 |
|||||
Amino acid metabolism disorder formula food |
1 |
Periflex / SHS |
0-12 months |
||
Premature or low birth weight infant formula food |
14 |
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 |
|||||
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 |
46 |
Pediasure / ABBOTT |
1-10 years 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 |
|||||
麦速®/ Jilin Maifu |
|||||
康素得臻膳/ Ausnutria Dairy |
|||||
康素得舒膳/ Ausnutria Dairy |
|||||
唯源全®/ YABAO |
|||||
唯源泰®/YABAO |
|||||
海维舒®/ Jiangsu Zhengda Fenghai |
|||||
海维安®/ Jiangsu Zhengda Fenghai |
|||||
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) |
|||||
Specific nutritionally complete foods |
Tumor |
1 |
速熠素/ Nestle |
Above 10 years old |
|
Nutritionally incomplete foods |
Electrolyte formula |
20 |
乐赋/ SUZHOU HENGRUI JIANKANG |
Above 10 years old |
|
艾诺利/Tibet DUOXIN |
|||||
卡捷®/ Jilin Maifu |
|||||
特颐欣/ YICHANG HUMANWELL |
|||||
葆畅佳/ CSPC Zhongnuo Yaoye |
|||||
冬泽畅康/ DAISY FSMP |
|||||
诺葆素®/Heibei Aisheng |
|||||
西泓源®/Jiangshu Xihong |
|||||
循畅®/ HAISCO PHARMACEUTICAL |
|||||
辰乐维®/ Cisen Pharmaceutical |
|||||
益护宁/ Zhejiang Yiyuansu |
|||||
循康®/ HAISCO PHARMACEUTICAL |
|||||
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 years old |
||||
Nutrient components |
24 |
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 |
|||||
卡乐全/ Shandong Ruoyao |
|||||
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 |
|||||
益护宁/ Zhejiang Yiyuansu |
|||||
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 years old |
||||
欣饴元/ Cisen Pharmaceutical |
|||||
Thickening components |
1 |
麦孚顺宝® Jilin Maifu |
Above 10 years old |
||
Liquid formula |
2 |
诺葆舒® /Heibei Aisheng |
Above 10 years old |
||
术和®/ Jilin Maifu |
|||||
Amino acid metabolism disorder formula |
2 |
Periflex Ad./SHS |
Above 10 years old |
||
Periflex®/SHS |
Table 1. Summary of the categories/types of the approved products
Summary and Analysis of the Applying Enterprises
A total of 43 enterprises have obtained FSMP registration certificates, 36 of which are domestic. Among the 140 products, Nestle has 15, the largest among others as an individual company. In addition, Nestle, Abbott, and NUTRICIA, as the world's leading FSMP enterprises, show a diversification trend in their products, while domestic enterprises have the phenomenon of product simplification.
The information for each enterprise to register FSMP is as follows.
Figure 2. Quantity of approved FSMP products by different companies
Summary and Analysis of Previously Registered FSMP Types
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, which were mainly registered in 2018 and 2019, while the registration of nutritionally incomplete food reached its peak in 2021.
There is no clear product category that is outperforming the other in 2022, 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 specific nutritionally complete food has broken the gap in the past years, which is undoubtedly great progress for FSMP. In the first three quarters of 2023, 46 new products have been added, and the first thickening component has been added. The registration types are mainly concentrated in nutritionally complete food and nutritionally incomplete food, accounting for 89%. Compared with the annual number of registrations in 2022, the number of registrations this year has shown explosive growth. The trend of registration types of the FSMP over the years is as follows:
Figure 3. FSMP registration types over the years
The above information is an analysis associated with the current situation of FSMP registration in China. Click to learn more about FSMP registration requirements in China.
Annex 1. Detailed information on the 140 approved FSMP products
Table 2. The 140 approved FSMP products
Note: 1. the general names in the table are updated according to the Notice on the Adjustment of the 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.
4. 优博启能infant nutrition supplement for special medical purposes was cancelled by application on August 17, 2022. The switch with 特爱启能infant nutrition supplement for special medical purposes (国食注字 TY20220006) shall be completed within three months from the approval date. After the switch, production shall not be allowed.
5. 南通励成“力存优太” changed its name to“力存优太®” on January 3, 2023.
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