抗肿瘤药说明书安全性信息上市后修订的考虑要点

doi:10.19803/j.1672-8629.20230609

摘要/Abstract

摘要： 目的介绍抗肿瘤药说明书安全性信息上市后修订的考虑要点,为药品上市许可持有人提供参考。方法基于国家药品监督管理局药品评价中心（简称“评价中心”）近年的修订实例,阐述修订目的、启动原因、决策证据以及修订原则。结果与结论 说明书安全性信息修订是一项系统工程。评价中心将持续致力于完善包括抗肿瘤药在内的各种药品说明书安全性信息。药品上市许可持有人应充分发挥主体责任,及时、主动完善说明书,保障人民群众用药安全。

关键词: 药品说明书, 安全性信息, 上市后, 修订, 抗肿瘤药, 药品上市许可持有人

Abstract: Objective To outline the considerations for the revision of safety information in package inserts of anti-cancer drugs in the post-market phase so as to provide reference for marketing authorization holders (MAH). Methods Based on the revision accomplished by the Center for Drug Reevaluation (CDR) of the National Medicinal Products Administration, the purpose, reasons, evidence and principles related to revision were presented. Results and Conclusion The revision of safety information in package inserts of drugs is a multi-departmental project. CDR will continue to improve the safety information for all authorized drugs in China, including anti-cancer drugs. MAH should fulfill their responsibility to improve drug package inserts in time so as to ensure the safe use of drugs.

Key words: package insert, safety information, post-market, revision, anti-cancer drug, drug marketing authorization holder

中图分类号:

R979.1

熊玮仪, 任经天. 抗肿瘤药说明书安全性信息上市后修订的考虑要点[J]. 中国药物警戒, 2024, 21(1): 94-97.

XIONG Weiyi, REN Jingtian. Considerations for revision of safety information in package inserts of anti-cancer drugs in post-market phase[J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 94-97.

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https://www.zgywjj.com/CN/Y2024/V21/I1/94

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