China Proposes Broad New Regulations on Medical Representatives

The China Food and Drug Administration (CFDA) issued draft rules on December 19, 2017 that would significantly tighten regulation of Medical Representatives (MRs) in the country. Among the proposed requirements, MRs must be registered on a CFDA administered website, must meet specific qualification requirements, and are not permitted to undertake “drug sales responsibilities”. The last requirement has drawn concern because it may give the government the power to regulate companies’ internal management of MRs. The draft regulations contain broad requirements for MRs, including training, sponsorship, and activities around hospitals. It prohibits them from “exaggerating or misleading” physicians on drug efficacy. Companies should closely monitor the development of the regulation and pay close attention to the new requirements to ensure compliance.