In Pink Sheet, Life Sciences Partner Examines Proposed Revision to China’s Drug Administration Law
Life sciences partner Katherine Wang (Shanghai) was quoted in a Pink Sheet article published on May 20. The article analyzes a proposed revision to China’s Drug Administration Law that will enforce Good Manufacturing Practice violations with large fines, while a dedicated law proposes additional scrutiny over imported vaccines.
China is accelerating a crackdown on drug product quality violations and counterfeit products with potential fines as high as 30 times the revenues obtained from illegal operations
Ms. Wang explains that while the proposed draft codifies many reform initiatives that accelerate market access of innovative drugs, it also signals aggressive post-approval enforcement and severe sanctions.