Updated on 4 June 2020
The State Administration for Market Regulation (SAMR) approved the registration application of 3 FSMP products on May 25, 2020. The detailed information are shown in the table below:
|
S.N. |
Applicant |
Product Name |
Certificate Number |
Issuing Date |
|
1 |
HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD. |
舒力乐 infant partially hydrolyzed milk protein formula for special medical purpose |
国食注字TY20200006 |
2020.5.25 |
|
2 |
YABAO Pharmaceutical Group Co., Ltd |
唯源素® nutritionally complete food (powder) for special medical purpose |
国食注字TY20200007 |
2020.5.25 |
|
3 |
Nestle Nederland B.V. |
ALFAMINO infant amino acid formula for special medical purpose |
国食注字TY20205001 |
2020.5.25 |
Summary and Analysis of the Approved FSMP in China
Up to now, totally 51 FSMP products have been approved in China. Among them, 21 products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1:
Table 1. The 51 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
As demonstrated above, among the 51 approved products, the dosage forms of 49 products are known (the information of the remaining products will be updated after the release), among which only 5 products are liquid, accounting for 10%, and the remaining are all powder products.
There are totally 18 companies obtaining FSMP registration certificates, while among the 51 products, 11 of them have been developed by one company – Nestle. Moreover, there are 11 domestic companies obtaining FSMP certificate in China.
Figure 1. Quantity of approved FSMP products at different companies
Among the 51 products, in terms of product type, as shown in the figure below, 31 of them are infant formula for special medical purposes, 4 are nutritionally incomplete food, and 16 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.
Figure 2. The approved products in different categories
The detailed information are shown in table 2.
Table 2. 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 ALFARE/ NESTLE Althera/NESTLE ALFAMINO/ NESTLE |
0-12 months |
|
|
Partially hydrolyzed milk protein formula food |
6 |
Eleva Care / ABBOTT Similac / ABBOTT EnfaGentlease / MEAD JOHNSON 优博敏佳/ SYNUTRA NAN H.A./Nestle 舒力乐/ HANGZHOU BEINGMATE |
0-12 months |
||
|
Lactose free formula or low lactose formula food |
6 |
Beingmate / HANGZHOU BEINGMATE 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 |
0-12 months |
||
|
Amino acid metabolism disorder formula food |
1 |
Periflex / SHS |
0-12 months |
||
|
Premature or low birth weight infant formula food |
11 |
Similac Neo / ABBOTT 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 |
0-12 months |
||
|
Infant nutrition supplement |
3 |
Similac HMFortifi/ ABBOTT 优博启能/ SYNUTRA 昔倍护/ HANGZHOU BEINGMATE |
0-12 months |
||
|
FSMP for people over the age of 12 months |
Nutritionally complete foods |
16 |
Pediasure / ABBOTT 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 |
1-10 year-old or above 10 years old |
|
|
Specific nutritionally complete foods |
0 |
NA |
NA |
||
|
Nutritionally incomplete foods |
Electrolyte formula |
2 |
乐赋/ SUZHOU HENGRUI JIANKANG |
Above 10 year-old |
|
|
乐棠/ SUZHOU HENGRUI JIANKANG |
Above 18 year-old |
||||
|
Nutrient components |
0 |
NA |
NA |
||
|
Thickening components |
0 |
NA |
NA |
||
|
Liquid formula |
0 |
NA |
NA |
||
|
Amino acid metabolism disorder formula |
2 |
Periflex Ad./SHS Periflex®/SHS |
Above 10 year-old |
||
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.
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