China Publishes New Good Distribution Practices

The Chinese Ministry of Heath (MOH) published on 22 January 2013 new requirements on Good Distribution - respectively on Good Supply Practices for Pharmaceutical Products. The new regulations apply not only to distributors but also to pharmaceutical manufacturers.

They will go into effect as of 1st June 2013. The new requirements are considerably much more extensive than the current Good Supply Practices. According to Ropes & Gray Alert, the MOH regulates questions about for example storage and transportation of medicinal products within 4 chapters and 187 paragraphs. In conformity with the new requirements wholesalers have to establish a comprehensivie quality management system including qualified personnel. Moreover, the requirements set on IT systems - which should ensure product traceability over the whole supply chain - have been extended. The requirements on storage conditions have been completed too - among them: dedicated requirements on storage and transportation conditions as well as special requirements for the cold-chain monitoring. So-called third party providers (companies which take over some operations - for example transportation services, external storage, etc. - on behalf of drug manufacturers or distributors) have to be observed too.

Distributors will have a pretty long grace period of three years to comply with the new requirements. This is a way for China to strengthen its GDP - respectively its GSP regulations. India had just recently published a Draft GDP Guide. Europe is also finalising a new GDP Guideline. In a word, legislators all over the world do react to the necessity to monitor and regulate more strictly the drugs supply chain. Transportation and storage conditions for APIs will also be regulated in Europe too. Recently, a draft on GDP for APIs has been released.

Sources: Ropes & Gray Alert, China FDA (SFDA) News