China aims to modernize traceability of pharmaceuticals

Moving to counter widespread criticism that its drug supply chain is unsafe and inefficient, Chinese health officials are moving to modernize the nation’s system for tracing pharmaceuticals.

In a flurry of recent moves, the China National Drug Administration (CNDA) has posted draft guidance on improving the ability to track shipments of drugs electronically as they move from lab to factory to market. If implemented, the measures would include a unique device identification system for products at each stage of manufacture and sale in China. Dubbed the National Drug Regulatory Information Standard and Traceability System, it would require drugs be identified with a new drug traceability code (DTC) consisting of at least 10 numbers, letters, and symbols.

The measures, which the Chinese expect companies doing business in the country to largely pay for, are designed to prevent substandard and fraudulent drug products from gaining a toehold in the Chinese market. They would also make it easier to recall products.

Chinese health officials have been working on similar improvements since 2016, when the CNDA first pledged to bring its serialization and traceability regulations into compatibility with international standards. But it has yet to implement the single system it promised. The new measures, which also include plans for a national system to monitor drugs by collecting and tracing product data,  would bring China closer than ever to that goal.