China SAMR Clarifies FSMP Registration Alteration Requirements

On Mar 12th, China SAMR clarified requirements and the deadline in which formula and labels must be amended after approval of FSMP registration alteration. The main contents are as follows:

1. Replace FSMP formulas and labels within three months, starting from the approval date of product formula and label registration change.

2. Stop using previous product formulae and labels and report the replacement to the local Administration for Market Regulation after changes are completed. 

3. Products produced before the alteration of the registration content can be sold until the expiration date. 

Need help with FSMP registration in China, please contact [email protected].  

Please see Administrative Measures for Registration of Foods for Special Medical Purpose for FSMP registration requirements in China.