The National Medical Products Administration’s Announcement on Further Strengthening Digital Drug Traceability Management reinforces traceability responsibilities throughout China’s pharmaceutical supply chain. It covers marketing authorisation holders, overseas holders’ designated domestic responsible persons, manufacturers, distributors, entities using medicines and traceability-system operators.
The requirements focus on operational controls at receipt and sale. Traceability alerts trigger the immediate suspension of receipt and sales, followed by verification reviewed and signed by the person responsible for quality. Products recorded as already sold through retail pharmacies or user entities must be rejected upon receipt, while sales receipts must display traceability codes or provide a convenient means of accessing them.
For pharmaceutical businesses, these measures make traceability an integral part of quality governance and distribution oversight. Integrating code verification, exception handling and quality-management approval into daily workflows strengthens control over product movements and helps prevent diverted medicines from re-entering the supply chain.