China Issues Draft Administrative Rules to Regulate Medical Representatives

In late 2024, the National Medical Products Administration of China (NMPA) and six other government agencies published the Draft Administrative Measures for Management of Medical Representatives (Draft Management Measures) to update the 2020 Record-Filing Measures. The goal of this publication is to further regulate medical representatives, Marketing Authorization Holders (MAHs), healthcare institutions, and healthcare providers (HCPs) activities.

Draft Management Measures extend the MAH’s responsibilities, which now include ensuring that medical representatives sign a commitment letter and possess sufficient academic and professional qualifications. In addition, MAHs are barred from hiring representatives with a conviction of commercial bribery. Filing requirements for MAHs have been expanded to include identification numbers for the representatives as well as their respective compliance records.

The measures will also assign new obligations to healthcare institutions. They are required to establish special internal departments to monitor and control the activities of medical representatives promoting drugs. Provisions also involve anti-off-label promotion, unlicensed collection of prescription data, and offering benefits to HCPs or their relatives.

The draft enforcement mechanisms provide for a collaborative framework among the NMPA, the Ministry of Public Security, and the State Administration of Market Regulation. Consequences for failure to comply might include disclosure of violations to the public, professional restrictions on representatives, and enhanced supervision of MAHs and healthcare institutions. Further penalties may result in exclusion from public procurement programs or denial of access to public insurance reimbursement systems.

The Draft Management Measures also facilitate whistleblower policies, while encouraging trade associations to form codes of practice. Nonetheless, ambiguities still exist. For example, MAHs are now responsible for overseeing representatives, but many of the representatives are employed by third-party distributors.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.