Abstract: Objective To give applicants specific advice on how to develop a post-marketing risk management plan for new drug applications in line with the E2E guidelines and the updated Drug Administration Law. Methods Based on the ICH E2E guidelines for pharmacovigilance planning, this article was intended to elaborate on the template for risk management plans(RMP) specified by the Requirements on Format and Content of the Risk Management Plan for Anti-tumor Drugs Application published by the Center for Drug Evaluation (CDE) of NMPA. Considerations about risk assessment during the clinical review of new drug applications were also mentioned. Results The CDE RMP template covered all key points stated by E2E guidelines. By using the framework of this template, this article gave specific instructions on how to identify important risks of a new drug and to develop appropriate pharmacovigilance plans and risk minimization measures that match the safety profile. Conclusion A qualified RMP can present the critical information on drug risks for the benefit-risk assessment, and persuasively demonstrate the confidence and ability of the applicants to manage risks. It can also facilitate the review process and improve the availability of valuable drugs. It is a promising tool for the control of full life cycle risks of a new drug.

Key words: risk management plan, safety, pharmacovigilance, risk minimization