E2E指导原则对中国创新药上市后风险管理的启发

Post-marketing Risk Management of New Drugs in China Inspired by E2E Guidelines

目的为中国创新药上市后风险管理提供思路。方法学习国际人用药品注册技术要求协调会(ICH)三方协调指导原则E2E的内容,参考欧美日三方E2E指导原则的执行情况,提出符合中国监管环境的创新药上市后风险管理建议。结果建议中国药品监管机构遵照E2E指导原则的精神,要求申请人在药品上市申请时提交一份独立的包含安全性说明和风险应对措施的风险管理计划,可首先应用于个别适应证的创新药,并根据执行过程中遇到的问题拟定技术指南和方法指导。结论加入ICH后,中国药品监管机构应该积极地以E2E指导原则为基准,对药品尤其是创新药提出上市后风险管理的要求。

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.