China Enforces New Quality Control Standards for Drugs

Starting July 1, 2013, all new pharmaceutical companies operating in China must comply with China’s Food and Drug Administration (CFDA) revised Drug Quality Control Standards for license approval and GMP certification. Pharmaceutical companies with new, expanded or renovated warehouses or business locations must also comply.

This is the first phase of a comprehensive overhaul of China’s Good Supply Practices (GSP) for approved drug products. The revised rules establish higher standards for quality controls in drug distribution and supply chain management, including warehouse storage conditions, electronic data storage, product documentation and quality assurance practices for drug transportation providers. All phases of the new rules are to be implemented by December 31, 2015.

For the first phase, new pharmaceutical companies that cannot meet a deadline of December 31, 2013 may apply for an extension until June 30, 2014. All pharmaceutical companies manufacturing or selling drugs in China must be compliant by the December 31, 2015 deadline, or face the suspension of their business.