CFDA Approved the First Batch of Foods for Special Medical Purpose (FSMP) and Extended the Transitional Period of FSMP Registration

1. The first batch of registered FSMP products under CFDA

On November 20, 2017, CFDA approved the registration application of 3 FSMP products from 2 enterprises. This is the first batch of FSMP products that obtain the approval under CFDA. All of them are infant formula foods for special medical purpose, and they are all from foreign enterprises.

The detailed information is as follows:

No.

Enterprise name

Product name

Registration number

Expiration date

1

SHS International Ltd

纽康特特殊医学用途婴儿配方粉氨基酸配方

(纽康特 amino acid formula of infant formula powder for special medical purpose)

国食注字TY20175001

2022.11.19

2

ABBOTT LABORATORIES S.A.

雅培亲护特殊医学用途婴儿配方粉乳蛋白部分水解配方

(雅培亲护partially hydrolyzed milk protein formula of infant formula powder for special medical purpose)

国食注字TY20175002

2022.11.19

3

ABBOTT LABORATORIES S.A.

菁挚呵护特殊医学用途婴儿配方粉乳蛋白部分水解配方

(菁挚呵护partially hydrolyzed milk protein formula of infant formula powder for special medical purpose)

国食注字TY20175003

2022.11.19

2. The transition period of FSMP registration is extended 

On November 22, 2017, CFDA issued a notice to adjust the transitional period of FSMP registration. The main arrangements are as follows: 

I. Since January 1 2019, all FSMP products produced in China or imported to China shall get the FSMP registration certificate under CFDA, and indicate the registration number on the label and instruction. 

II. If the production dates of the domestic or imported FSMP products are before December 31, 2018, the products can be sold in China until the end of expiration date.   

Previously, the transition period is the end of 2017. But now, it is extended for one year, which give relevant enterprises more time to apply for the FSMP registration.

For more information about the FSMP registration in China, please kindly click here.

If you have any other needs and questions, please contact us at service@cirs-reach.com.

Reference:

http://www.sfda.gov.cn/WS01/CL0050/217140.html