The State Administration for Market Regulation (SAMR) approved the registration application of 2 FSMP product on March 11, 2020, the detailed information are shown in the table below:
|
S.N. |
Applicant |
Product Name |
Acceptance Number |
Issuing Date |
|
1 |
AusNuotore |
爱优诺优益力 nutritionally complete food for special medical purpose |
国食注申TY20180034 |
2020.3.11 |
|
2 |
AusNuotore |
爱优诺优康力 nutritionally complete food for special medical purpose |
国食注申TY20180038 |
2020.3.11 |
Note: The registration certificate number and registration expiry date of the products are marked with "-" in table 1, and will be supplemented after relevant information are published
Summary and Analysis of the Approved FSMP in China
Until now, totally 45 FSMP products have been approved in China (not 46 but 45, the mistake results from the expression matters of the official website, in the statistics of this article, they are corrected already). Among them, 16 products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1:
Table 1. The 45 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 45 approved products, the dosage forms of 41 products are known (the information of the remaining products will be updated after the release), among which only 5 products are liquid, accounting for 12%, and the remaining are all powder products.
There are totally 15 companies obtaining FSMP registration certificates, while among the 45 products, 10 of them have been developed by one company – Nestle. Moreover, there are 8 domestic companies obtaining FSMP certificate in China.
Figure 1. Quantity of approved FSMP products at different companies
Among the 45 products, in terms of product type, as shown in the figure below, 29 of them are infant formula for special medical purposes, 4 are nutritionally incomplete food, and 12 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 |
3 |
Neocate / SHS ALFARE/ NESTLE Althera/NESTLE |
0-12 months |
|
|
Partially hydrolyzed milk protein formula food |
5 |
Eleva Care / ABBOTT Similac / ABBOTT EnfaGentlease / MEAD JOHNSON 优博敏佳/ SYNUTRA NAN H.A./Nestle |
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 |
12 |
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 |
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 are 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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