Updated on March 8, 2023
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 104.
Companies must register FSMP products with the SAMR. This applies to both imported products as well as those produced domestically and marketed in China. Ten new FSMP Products have been approved for use in February 2023:
- five nutritionally complete foods;
- four nutritionally incomplete foods; and
- one infant formula for special medical purposes.
Summary and Analysis of the FSMP Approved for Use in China
At present, a total of 104 FSMP products have been approved in China, including 74 domestic products and 30 foreign products. Among the 104 approved products, 80 products are powder, and 24 products are liquid.
The following product types have been approved:
- 39 infant formulas for special medical purposes;
- 36 nutritionally incomplete food;
- 28 nutritionally complete food; and
- one 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 104 products(the information is taken form the SAMR’s website).
Figure 1. Different categories of approved products
Relevant information is listed 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 | 5 | Neocate / SHS | 0-12 months | |
ALFARE/ NESTLE | |||||
Althera/NESTLE | |||||
ALFAMINO/ NESTLE | |||||
Pepti Junior/Nutricia | |||||
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 | 28 | Pediasure / ABBOTT | 1-10 year-olds 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/澳优乳业 | |||||
康素得舒膳/澳优乳业 | |||||
唯源全®/ YABAO | |||||
唯源泰®/YABAO | |||||
Specific nutritionally complete foods | Tumor | 1 | 速熠素/ Nestle | Above 10 years-old | |
Nutritionally incomplete foods | Electrolyte formula | 14 | 乐赋/ SUZHOU HENGRUI JIANKANG | Above 10 years-old | |
乐棠/ SUZHOU HENGRUI JIANKANG | Above 18 years-old | ||||
艾诺利/Tibet DUOXIN | Above 10 years-old | ||||
恬能®/ Jiangsu Zhengda Fenghai | 10-14 years old | ||||
乐潼/ SUZHOU HENGRUI JIANKANG | 1-10 years-old | ||||
君蓓乐维/GUANGDONG JUNJOY | Above 1-year-old | ||||
枢能/ YICHANG HUMANWELL | Above 18 years-old | ||||
若新/ Shandong Ruoyao | Above 18 years-old | ||||
卡捷®/ Jilin Maifu | Above 10 years-old | ||||
贝耶/ Shandong Ruoyao | 10-14 years-old | ||||
特颐欣/ YICHANG HUMANWELL | Above 10 years-old | ||||
葆畅佳/ CSPC Zhongnuo Yaoye | Above 10 years-old | ||||
冬泽畅康/ DAISY FSMP | Above 10 years-old | ||||
诺葆素®/Heibei Aisheng | Above 10 years-old | ||||
Nutrient components | 17 | 伊能佳®/Zhejiang海正甦力康 | 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 | |||||
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 | ||||
Thickening components | 0 | NA | NA | ||
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 |
A total of 38 have obtained FSMP registration certificates, 31 of which are from domestic companies. Among the 104 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 eight registrations by Abbot Laboratories. In addition, Nestle, Abbott, and NUTRICIA, as the world's leading FSMP enterprises, have diversified products. And 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
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 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.
There is no clear product category that outperformed others in 2022, but it did see 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 beginning of 2023, the registration of FSMP products is mainly nutritionally complete food and nutritionally incomplete food. 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 on the 104 approved FSMP products
Table 2. The 104 approved FSMP products
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.
4. 优博启能infant nutrition supplement for special medical purpose was cancelled by application on August 17, 2022. The switch with 特爱启能infant nutrition supplement for special medical purpose (国食注字 TY20220006) shall be completed within 3 months from the approval date. After the switch, production shall not be allowed.
5. 南通励成“力存优太”change its name to“力存优太®”on January 3,2023.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.