The formula food for special medical purposes shall be registered by food and drug administration departments under the State of Council according to Article 80 of the Food Safety Law.

 

On March 7, 2016, China Food and Drug Administration issued the “Administrative measures for the registration of formula food for special medical purposes” (No. 24 of China Food and Drug Administration).

 

On June 24, 2016, the China Food and Drug Administration issued an announcement about the transitional period for registration administration of formula food for special medical purposes (No. 119, 2016), which gave a transitional period till January 1, 2018.

 

On July 14, 2017, CFDA issued the related auxiliary documents of “Administrative Measures for Registration of FSMP” including trial editions of four document, i.e. items and requirements of application materials, requirements of food label and specification, requirements of stability research and main on-site inspection points & judgment principle.

 

On September 5, 2017, “Items and requirements of application materials for registration of formula food for special medical purposes (trial) (2017 revised edition)” and “Stability research requirements for formula food for special medical purposes (trial) (2017 revised edition)” (2017 revised edition) were issued.

 

On November 16, 2017, CFDA and AQSIQ jointly issued the announcement about adjusting the transitional period for registration of FSMP (No. 139 of 2017), which prolonged the transitional period stipulated in Announcement No. 119 of 2016 by one year till January 1, 2019. Since January 1, 2019, the FSMP produced within the territory of our country or imported to our territory shall obtain the registration certificate of FSMP with registration number indicated in the label and specification. Where the date of manufacture is before December 31 of 2018 (included), it can be sold until the expiration date within the territory of our country.