China's National Medical Products Administration (NMPA) drug traceability system requires all drugs sold in China to be serialised and tracked through the supply chain. The system, implemented progressively from 2019, covers vaccines (fully mandatory since 2019) and all other drugs (mandatory since 2020).
Serialisation Requirements
All drugs sold in China must carry a unique identifier at the minimum saleable unit level. The identifier must be encoded in a 2D barcode (DataMatrix or QR code) and must contain: a product code; a serial number; a lot number; and an expiry date. The format follows GS1 standards or the NMPA's proprietary encoding format.
Reporting Obligations
Pharmaceutical manufacturers, importers, wholesale distributors, and retail pharmacies must report traceability data to the NMPA's national drug traceability platform. Reporting events include: production/import; wholesale distribution; retail dispensing; and destruction/recall. Data must be reported within specified timeframes after each event.
Compliance for Foreign Companies
Foreign pharmaceutical companies exporting to China must: register their products with the NMPA; implement serialisation on packaging destined for China; and report traceability data to the NMPA platform through their Chinese marketing authorisation holder (MAH) or authorised agent. Non-compliant products may be refused entry at Chinese customs.