Chinese Pharmaceutical, Biotech, and Medical Device Industry Associations Issue First Comprehensive Compliance Guidelines

Chinese Pharmaceutical, Biotech, and Medical Device Industry Associations Issue First Comprehensive Compliance Guidelines

April 28, 2021, Covington Alert

In late March 2021, five prominent Chinese pharmaceutical, biotech, and medical device associations released the Pharmaceutical Industry Compliance Management Practices (医药行业合规管理规范, the “Compliance Standards”), the first comprehensive compliance guidelines tailored for life sciences companies operating in China.  (Despite the title, the Compliance Standards apply to all life sciences companies, not only pharma companies.) The anti-bribery/anti-corruption section of the Compliance Standards provides detailed guidance that, with a few exceptions, aligns with the requirements from codes of conduct issued by industry associations for multinational life sciences companies, such as the RDPAC Code of Practice and the AdvaMed Code of Ethics on Interactions with Health Care Professionals in China (“AdvaMed China Code”). The Compliance Standards provide life sciences companies in China with a high-level compliance framework across different enforcement areas.