如何撰写符合E2E指导原则的新药上市后风险管理计划

doi:10.19803/j.1672-8629.2020.11.07

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (11): 780-784.
DOI: 10.19803/j.1672-8629.2020.11.07

如何撰写符合E2E指导原则的新药上市后风险管理计划

邹丽敏, 齐玥丽, 唐凌, 杜瑜, 杨志敏^*

国家药品监督管理局药品审评中心,北京 100022

收稿日期:2020-11-10 修回日期:2020-11-10 出版日期:2020-11-15 发布日期:2020-11-10
通讯作者: ^*杨志敏,女,本科,主任药师,药品临床审评。Email: yangzhm@cde.org.cn
作者简介:邹丽敏,女,博士,助理研究员,药品临床审评。

How to Develop a Post-marketing Risk Management Plan for New Drug Applications in Line with E2E Guidelines

ZOU Limin, QI Yueli, TANG Ling, DU Yu, YANG Zhimin^*

Center for Drug Evaluation, National Medicine Products Administration, Beijing 100022, China

Received:2020-11-10 Revised:2020-11-10 Online:2020-11-15 Published:2020-11-10

摘要/Abstract

摘要： 目的为新药在中国申报上市拟定风险管理计划（RMP）提供撰写思路和建议,以符合E2E指导原则并满足新修订《中华人民共和国药品管理法》的法规要求,并符合药品监管机构预期。方法以E2E指导原则为基准,结合新药审评过程中对风险评价的考虑,对国家药品监督管理局药品审评中心肿瘤适应证小组发表的电子刊物《抗肿瘤药物上市申请时风险管理计划撰写的格式与内容要求》中所包含的RMP模板进行详解和要点剖析。结果药品审评中心提供的RMP模板涵盖了E2E指导原则所要求的新药风险管理的关键要素。以此模板为框架,本文针对如何分析和提炼新药的重要风险,以及如何撰写与风险相匹配的药物警戒计划和风险最小化措施,从临床审评员的视角作出详细解读。结论撰写一份高质量的RMP,能为审评单位提供获益风险评估过程中的重要风险信息,明确风险管理手段,能正向影响审评效率从而加快有临床价值的新药上市,也为新药上市后的全生命周期风险管理提供依据。

关键词: 风险管理计划, 安全性, 药物警戒, 风险最小化

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

中图分类号:

R951

邹丽敏, 齐玥丽, 唐凌, 杜瑜, 杨志敏. 如何撰写符合E2E指导原则的新药上市后风险管理计划[J]. 中国药物警戒, 2020, 17(11): 780-784.

ZOU Limin, QI Yueli, TANG Ling, DU Yu, YANG Zhimin. How to Develop a Post-marketing Risk Management Plan for New Drug Applications in Line with E2E Guidelines[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 780-784.

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如何撰写符合E2E指导原则的新药上市后风险管理计划

How to Develop a Post-marketing Risk Management Plan for New Drug Applications in Line with E2E Guidelines

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