New Chinese drug laws: Foreign pharma exporters must also comply

New, more stringent legislation adopted by China’s State Drug Administration (SDA) raises the stakes for pharmaceutical exporters to that country.

China, the world’s second largest pharmaceutical market after the United States, enacted the Vaccine Administration Law (VAL) and revamped Drug Administration Law (DAL) in the wake of a falsified-vaccine scandal that resulted in Changchun Changsheng Life Sciences being fined $1.32 billion and subsequently declaring bankruptcy.

The legislation establishes uniform traceability standards for drugs and vaccines, requiring the tracking and reporting of data such as production and packaging information, validity, manufacturing date, and the identities of medical workers and recipients. Traceability information will have to be exchanged among trading partners along the supply chain, reported to the government and kept for a minimum of five years.

While the legislation came into effect Dec. 1, 2019, the SDA is still ironing out the details of how traceability data will be reported and exchanged. The deadline for those details to be finalized and put into effect is March 31, 2020.

In addition to domestic stakeholders, foreign drug license holders, pharmaceutical production and trading companies, and medical institutions that export drugs to China are all required to comply with the new traceability regulations. The Chinese government has promised stringent penalties for non-compliance.

 

 

Sanjay Sonar

Subject Matter Expert – Traceability

OPTEL

 

HOW OPTEL CAN HELP

OPTEL’s full-stack track-and-trace technologies can help your business comply with all worldwide regulations while guiding you along the next crucial steps toward a more intelligent supply chain.

All OPTEL solutions that supported China’s previous regulations will be able to ensure compliance with the new tracking and reporting requirements. Contact your account director for details.