Abstract: Objective To provide suggestions to conduct risk management plan in China by introducing the development, implementation elements and implementation effect of risk management plan (RMP) in European Union. Methods The material of RMP in European Union was summarized through analyzing literature and searching European Medicines Agency (EMA) official website. Results European Union regulations require marketing authorization applicant (MAA) / marketing authorization holder (MAH) develop RMP to ensure drug risk-benefit balance, with perfect regulations and guidelines and organization structure, and has achieved good results. Conclusion China could require companies to develop RMP from a legal perspective, and improve the relevant system, promote the development of RMP, so as to achieve full life-cycle drug risk management.

Key words: risk management plan, registration, risk management