The Good Supply Practice for Pharmaceutical Products (GSP) has been issued by the MOH on 22 Jan 2013 and will come into effect on 1 Jun 2013. The new GSP is a continued effort by the government to standardize the industry following the issue of GMP 2010, which would facilitate the upgrade of the pharmaceutical distribution chain and assure drugs quality.

The new GSP contains 4 chapters of 187 articles, addressing mainly on the quality control of wholesale and retails. It represents higher standards by the SFDA to regulate the entire drug distribution process, including purchase and sale, check and acceptance, storage, delivery, post-sales services, etc. It introduces advanced experience of the WHO and the European Good Distribution Practices for Pharmaceutical Products (GDP), the following are some of the key points of the new GSP,

• Adoption of the concept of supply chain management (SCM) and quality risk management (QRM);
• New requirements for the storehouse temperature and humidity automatic detection and cold-chain management;
• Management of equipment for storage and delivery;
• Higher requirements for the staff;
• Establishment of information management system to achieve traceability of the distribution process.

Currently, ithere are about 13,000 wholesalers and 420,000 retailers in China. The new GSP will raise the threshold for pharmaceutical distribution industry to drive the small-scale distributors out of the industry, so that industry consolidation in the pharmaceutical distribution sector could be achieved. The release of the new GSP will favor the major pharmaceutical distribution companies in mergers and acquisitions and integration campaign.

A three-year grace period will be granted for the wholesalers and retailers since 1 Jun 2013 when the new GSP come into effect. Those failing to meet the new GSP requirements after 1 Jun 2016 would have a chance of being excluded from the market.

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