As of August 14th, 2018, 16 FSMP products have been approved by China government. Among them, five products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1:
Table 1. The 16 approved FSMP products
There are totally 7 companies obtaining FSMP registration certificates, while among the 16 products, 5 of them have been developed by one company – ABBOTT. Meanwhile, there are 5 products developed by domestic companies -- HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD, SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD and SYNUTRA INTERNATIONAL INC.
Figure 1. Quantity of approved FSMP products at different companies
Among the 16 products, in terms of product type, 13 of them are infant formula for special medical purposes, 2 are nutritionally incomplete foods, and 1 is nutritionally complete food. While the breast milk nutrition foods and specific nutritionally complete foods have not been approved until now. 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 |
1 |
Neocate / SHS |
0-12 months |
|
|
Partially hydrolyzed milk protein formula food |
4 |
Eleva Care / ABBOTT Similac / ABBOTT EnfaGentlease / MEAD JOHNSON 优博敏佳/ SYNUTRA |
0-12 months |
||
|
Lactose free formula or low lactose formula food |
2 |
Beingmate / HANGZHOU BEINGMATE Enfagrow / MEAD JOHNSON |
0-12 months |
||
|
Amino acid metabolism disorder formula food |
1 |
Periflex / SHS |
0-12 months |
||
|
Premature or low birth weight infant formula food |
5 |
Similac Neo / ABBOTT Similac Gro / ABBOTT 早瑞能恩/ NESTLE Enfapro/ MEAD JOHNSON 优博安能/ SYNUTRA |
0-12 months |
||
|
Breast milk nutrition food |
0 |
NA |
NA |
||
|
FSMP for people over the age of 12 months |
Nutritionally complete foods |
1 |
Pediasure / ABBOTT |
1-10 year-old |
|
|
Specific nutritionally complete foods |
0 |
NA |
NA |
||
|
Nutritionally incomplete foods |
Electrolyte formula |
2 |
舒乐加/ 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 |
0 |
NA |
NA |
||
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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