On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction with six other government agencies. The Draft Management Measures were issued for public comment, with a deadline of December 13, 2024.
Although the Draft Management Measures’ title references medical representatives, i.e., sales representatives, their content is much broader, providing substantive requirements for and restrictions on the conduct of Marketing Authorization Holders (MAHs), healthcare institutions, and healthcare providers (HCPs). Once effective, the Draft Management Measures will replace the previous Administrative Measures for Management of Record-Filing for Medical Representatives (Trial Version) (the Record-Filing Measures, 医药代表备案管理办法(试行), which have been in effect since December 1, 2020. The Draft Management Measures are consistent with recent regulations issued for and enforcement trends in China’s healthcare industry, including the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks released on October 11, 2024.
Read our Advisory for an overview of the Draft Management Measures, including new requirements, prohibitions, and enforcement measures.