The National Medical Products Administration has restarted the electronic supervision code, accelerating the development of an information-based drug traceability system.
Release time:2025-09-29
On August 24, the website of the National Medical Products Administration (NMPA) published “The NMPA Office’s Public Solicitation of Comments on the ‘Guiding Opinions on the Construction of a Pharmaceutical Information Traceability System (Draft for Comments)’,” and is now openly soliciting public input. To date, discussions within the industry continue unabated.
Key points
The draft for comments proposes that holders should fulfill their responsibilities for the information-based traceability management of pharmaceutical products. In accordance with the coding requirements set forth by the drug regulatory authorities, they should assign traceability identifiers to sales packaging units at all levels of the product to achieve information-based traceability.
When procuring pharmaceutical products, wholesale drug enterprises shall request relevant traceability information from upstream enterprises and verify such information during product acceptance. When selling pharmaceutical products, they shall provide the relevant traceability information to downstream enterprises or medical institutions. Pharmaceutical retail and usage units, when procuring pharmaceutical products, shall also request relevant traceability information from upstream enterprises and verify such information during product acceptance. When selling pharmaceutical products, they shall maintain detailed sales records and promptly update the corresponding status indicators for sold products.
Industry insiders generally believe that Ali Health possesses years of mature and sophisticated traceability services (including electronic supervision and expertise). From the early days when the pharmaceutical electronic supervision code system was managed by Hebei Huiyan Pharmaceutical, a subsidiary of Ali Health, to the third-party traceability platform “Ma Shang Fang Xin,” numerous pharmaceutical companies have been using Ali’s pharmaceutical electronic platforms for many years. Moreover, the equipment and facilities installed by pharmaceutical companies for assigning and scanning electronic supervision codes are fully compatible with Ali’s platform. For these companies, Ali, as a trusted third party, represents an important option. The construction of a robust traceability system is crucial for pharmaceutical products, which are critical commodities directly related to human life safety and health. Any issue occurring at any stage—from raw material procurement and manufacturing to distribution and use—could affect the efficacy of the drug, the severity of side effects, or even the timing of emergency treatment. Therefore, traceability of pharmaceutical quality and safety is particularly vital. A pharmaceutical traceability system can collect and record information from various stages including production, distribution, consumption, and use, and leverage computerized information management systems for effective oversight. This enables traceability of origins, accountability of destinations, and clear assignment of responsibilities, thereby strengthening comprehensive quality management and risk control throughout the entire product lifecycle.
Relevant information
4/F, Building A1,No.10 Xicheng Zhong Street, Huangpu District, Guangzhou ,China.(510700)
WeChat Official Account