Abstract: Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics.

Key words: Ethics and Governance of Artificial Intelligence for Health, artificial intelligence (AI), ethics, governance, guidance, World Health Organization (WHO), medicine and health