China Issues Whistleblower Incentives for Drug and Medical Device Safety Violations

China Issues Whistleblower Incentives for Drug and Medical Device Safety Violations

China’s National Medical Products Administration (NMPA), Ministry of Finance (MoF), and State Administration for Market Regulation (SAMR) jointly issued the “Announcement on Rewarding Whistleblowers for Reporting Drug and Medical Device Quality and Safety Violations,” effective immediately. The announcement outlines measures to reward individuals who report serious violations in the drug and medical device sectors.

Whistleblower Rewards and Criteria
The policy clarifies that enterprises, users of drug and medical devices, third-party platform providers for online transactions, and internal employees or relevant insiders of other organizations can receive rewards for reporting serious violations with their real names to the drug regulatory department. “Major violations” include criminal offenses or administrative penalties such as orders to suspend production or business operations, revocation of licenses, and substantial fines.

Reward Procedure
The drug regulatory department responsible for reporting, investigating, and making the final decision must inform the whistleblower within 15 working days after the case is closed. The whistleblower must apply to initiate the reward procedure within 30 working days of being notified. In special circumstances, the deadline for receiving the reward may be extended by up to 10 working days. Whistleblowers are protected from retaliation, and enterprises or units found to retaliate will be severely punished.-Fineline Info & Tech