Announcement of State Food and Drug Administration

Notice

No.1 in 2015

Announcement on issues related to the full implementation of drug electronic supervision by drug manufacturing and trading enterprises

  In order to complete the task of "improving the drug electronic supervision system covering the whole variety, whole process and traceability" required by the 12th Five Year Plan of national drug safety on schedule, and to realize the electronic supervision of all drug preparation varieties, all production and circulation processes by the end of 2015, the drug production, trading enterprises and imported drug manufacturers are now related to the implementation of drug electronic supervision The announcement is as follows:

  Before December 31, 2015, all domestic pharmaceutical preparation manufacturers and imported pharmaceutical manufacturers shall be incorporated into the China drug electronic regulatory network (hereinafter referred to as "access"), and the transformation of production line shall be completed in accordance with the requirements of the original notice of the State Food and Drug Administration on printing and distributing guidance on drug electronic regulatory work (SFDA [2012] No. 283) China drug electronic supervision code (hereinafter referred to as "assigned code") with unified identification shall be printed (pasted), and data shall be collected and uploaded for verification and verification through China drug electronic supervision platform. All drug preparations produced after January 1, 2016 shall be coded.
  Before December 31, 2015, all drug wholesale and retail enterprises must enter the network, strictly in accordance with the requirements of the newly revised "quality management specifications for drug distribution", check and write off, upload information in a timely manner, ensure the integrity and accuracy of the data, and carefully handle the early warning information in the drug electronic supervision system.

  Before April 30, 2015, the pharmaceutical manufacturers of imported drugs that have not yet entered the Internet shall report their designated agency for drug electronic supervision to the State Food and drug administration, and start the implementation of Internet access in accordance with the requirements of the notice of the former State Food and Drug Administration on matters related to the implementation of electronic supervision of imported drugs (SFDA [2013] No. 23).

  Pharmaceutical production and trading enterprises and agencies for electronic supervision of imported drugs shall actively participate in learning and training, optimize equipment and systems, reasonably transform the operation process, and complete the implementation of electronic supervision of drugs, such as access to the Internet, coding, uploading, verification and verification according to the requirements, in accordance with the deployment of local provincial food and drug regulatory authorities.
 
Food and Drug Administration
January 4, 2015