On October 10, 2024, the National Medical Products Administration in China released the Draft Rule on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (the Draft Rule) for public comment, due by November 9, 2024. The Draft Rule marks a milestone in the development of China’s regulatory system for pharmaceuticals and medical devices and, like the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks recently published by the State Administration for Market Regulation, reflects Chinese regulators’ increasing use of best practices from other jurisdictions as well as their continued focus on the healthcare sector. Once effective, the Draft Rule may lead to more enforcement actions by Chinese authorities.
Pharmaceutical and medical device companies operating in China should continue to monitor the development of the Draft Rule, and may wish to take this opportunity to review their internal quality and safety systems as well as their internal reporting systems for their China operations. If you have any questions about the above topics, please feel free to contact the authors of this Advisory or other members of Arnold & Porter’s Life Sciences & Healthcare Regulatory or White Collar teams.
Read our Advisory for more information on the Draft Rule’s background and applications, as well as the channels for reporting issues, methods for handling reports, rewards for whistleblowers, and the confidentiality and anti-retaliation provisions set forth in the draft.