The Shanghai Medical Products Administration has issued updated guidelines for modern drug logistics, which took effect on Nov 7.
The new rules apply to newly established drug wholesale enterprises as well as those providing entrusted drug storage and transportation services. Existing companies are encouraged to gradually align with the updated standards.
The guidelines aim to optimize resource allocation, promote commercialization and standardized operations, and ensure drug quality and safety throughout the logistics process.
For new wholesale enterprises, warehouses must cover a minimum area of 10,000 square meters or a volume of 50,000 cubic meters, with automated systems occupying at least 25,000 cu m.
Cold chain logistics providers are required to operate at least two independent cold storage units with a total volume of 500 cu m.
Enterprises engaged in entrusted services face stricter criteria, requiring warehouses of 15,000 sq m or 75,000 cu m and at least eight dedicated transport vehicles.
All enterprises must implement integrated information systems, including warehouse and transportation management and temperature monitoring, enabling real-time data tracking.
The use of electronic data exchange platforms is mandatory for entrusted services to ensure seamless communication between parties and end-to-end traceability.
Required equipment includes barcode scanners, radio frequency identification technology, and automated conveyor systems to minimize operational errors.
The guidelines also support multi-warehouse coordination, allowing enterprises within unified quality management systems to share resources across regions.
In addition, eligible companies may integrate wholesale-retail operations under consolidated management for eligible companies.
The guidelines will remain in effect for five years, until Nov 6, 2030.
Source: Shanghai Observer