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CHINA FOOD AND DRUG ADMINISTRATION ISSUES THE REGISTRATION LIST OF FIRST BATCH OF FORMULA FOOD FOR SPECIAL MEDICAL PURPOSES AND ADJUSTS THE RELATED TRANSITIONAL PERIOD

China

Jan 04, 2019

On November 20, 2017, the China Food and Drug Administration approved and published the registration of 3 formula foods for special medical purposes of two enterprises.

The formula food for special medical purposes needs to be registered with the 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 on composition, labelling and specification as well as requirements on stability research, the main on-site inspection points and the 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 onadjusting the transitional period for registration of FSMP (No. 139 of 2017), which prolonged the transitional period stipulated in Announcement No. 119 of 201 with one year until January 1, 2019. Before that date, FSMP produced within the territory of our country or imported to our territory should obtain a specific FSMP registration certificate including a registration number which needs to be indicated on the label and the specification. In case the date of manufacture is before 31 December 2018 (the day itself included), the product can be sold until the expiration date within the territory of our country.

 

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