On April 25, the Ministry of Health of China (MOH) published a new draft of the Drug GSP for public comment, and key changes are:

  • The current Drug GSP, which became effective in July 2000, has only 88 articles. The draft new Drug GSP has 201 articles, and significantly expanded requirements on drug safety.
  • The draft new Drug GSP requires drug wholesalers to calibrate or qualify measuring devices, temperature and humidity monitoring devices and cold storage transportation equipment periodically, to set up computer system to cover the entire distribution process and satisfy quality control requirements, and to examine the qualifications of the sales personnel of the supplier.
  • The draft new Drug GSP imposes detailed requirements on control measures drug wholesalers need to take for drugs with quality defects. Drug wholesalers are required to stop the sales of such drugs immediately, and dispose of such drugs under the supervision of government authorities.
  • Drug retailers are required to stop the sales of drugs suspected with quality defects immediately, and retain relevant records. If any customer complains about counterfeit drugs or inferior drugs, drug retailers are required to report to government authorities and stop to sell such drugs, examine drugs of the same type but different batch number and drugs purchased from the same supplier, and dispose of such drugs under the supervision of government authorities.
  • The draft new Drug GSP provides for detailed qualification requirements of sales personnel at drug retail stores. Working staff at drug retail stores need to be their own employees, and sales representatives of drug manufacturers or wholesalers cannot work at drug retail stores.

The comment period of the draft new Drug GSP will close on May 27, 2012.