China Publishes New Good Distribution Practices - 02 Apr 2013
The Chinese Ministry of Health (MOH) on the 22 January 2013 published new requirements on Good Distribution and Good Supply Practices for Pharmaceutical Products. The new regulations apply to both distributors and also to pharmaceutical manufacturers.
These requirements become effective from the 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 comprehensive quality management system including the presence of qualified personnel. Moreover, the requirements set on IT systems – designed to ensure product traceability over the whole supply chain – have been extended. The requirements on storage conditions have also been further defined: dedicated requirements on storage and transportation conditions as well as special requirements for the cold-chain monitoring. In addition, 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 comply with these regulations too. Distributors will have a grace period of three years to comply with the new requirements. This also enables China to strengthen its GDP & GSP regulations.
Generally, there is a concerted effort globally to closely monitor & regulate drug supply chain. For instance, India recently published a draft GDP guideline and Europe is in the final process of establishing a new GDP guideline for both drug products and APIs.