The China Food and Drug Administration ("CFDA") has issued the revised draft Quality Control Standards for Pharmaceutical Distribution (GSP) (the “Draft”) which is open for public comment until 23 March 2016. The purpose of this Draft is to remove the current Drug Electronic Supervision System and build up a Drug Tracing System which can be used to search for and find information on the source of drugs, distribution of drugs and responsible parties.
This amendment is made on the basis of a significant number of recommendations from drug manufacturers, distributors, industry associations and experts. According to the Draft, the basic principles and requirements of the new Drug Tracing System have been clarified; the term “drug electronic supervision” has been replaced with “drug tracing”; all requirements regarding mandatory scanning and the electronic uploading of a monitoring code have been deleted or revised; and the requirement that computer systems must be available to implement an electronic drug supervising system has been deleted or revised.
Please see the Draft (Chinese only) here.