New rules on drug quality target circulation

BEIJING - The State Food and Drug Administration (SFDA) on Tuesday released a newly-revised regulation on Good Supply Practices (GSP) for drugs, urging greater risk-control capabilities for drug distributors during the circulation stage.

According to Li Guoqing, a senior SFDA official, the 187-article GSP regulation stipulates detailed quality management standards for both wholesalers and retailers.

Li said improvements related to purchase channels, storage temperatures, the keeping of receipts and other documents, cold-chain management and transportation have been included in the revision.

According to the revised rules, invoices must be issued for drug procurement and the transportation of drugs must be accompanied by matching document records.

For transportation conducted by third-party groups, consigners should first review their transfer capacities and sign liability agreements in case the quality of the drugs cannot be maintained during the transportation process.

The rules also raise requirements concerning the storage and transfer of cold-chain drug products, with detailed stipulations on temperature monitoring, tracking and product checks upon reception.

The regulation will take effect on June 1. However, according to Li, related drug enterprises will have a three-year transition period to adjust to the new rules. Those that are not able to do so after 2016 will be banned from selling drugs.