China’s NMPA Tightens Drug Traceability Requirements

China’s drug regulator is tightening the rules on pharmaceutical traceability. The NMPA  has ordered drug marketing authorization holders, local agents, manufacturers, distributors, and end users to fully implement traceability across the supply chain. Every eligible drug product must now carry a unique traceability code, and scanning that code will be mandatory at each step of the supply chain.

License holders and manufacturers must register their products on the National Drug Traceability Collaborative Service Platform and activate codes before products reach the market. They must also record warehousing and shipment information in the system. Distributors and retailers must scan and verify codes when products arrive. If the system flags something unusual, they must halt operations and investigate before resuming sales.

Enforcement will run through routine inspections. Provincial regulators are expected to incorporate traceability checks into their regular oversight and penalize violations under existing pharmaceutical laws.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.