关键词: E2E指导原则, 风险管理, 创新药

Abstract: Objective To propose new ideas on post-marketing risk management of new drugs in China. Methods By reviewing the ICH harmonized tripartite guideline pharmacovigilance planning E2E, and drawing lessons from the practices of regulatory bodies of the European Union, Japan and USA, suggestions on post-marketing risk management of new drugs were raised in line with the regulatory environment of pharmaceuticals in China. Results To comply with E2E, China’s regulatory bodies are to require that a risk management plan composed of safety specifications and risk counter-measures should be included in the dossiers of drug marketing authorization applications, especially applications related to a new entity. Regulatory bodies assume the responsibility to offer solutions and guidance to applicants to address issues and challenges during implementation. Conclusion Regulatory bodies in China should be faithful to the ICH commitment by following the E2E guidelines to promote the post-marketing risk management of drugs, new entities in particular, which conforms to the current regulatory environment of pharmaceuticals in China and can benefit patients.

Key words: E2E guidelines, risk management, new drug