定期获益-风险评估报告在我国的实施思考

doi:10.19803/j.1672-8629.20230579

摘要/Abstract

摘要： 目的结合我国当前药品监管形势,探讨《药品不良反应报告和监测管理办法》（简称“81号令”）修订工作中定期汇总报告的修订考虑。方法介绍国际人用药品注册技术协调会（ICH）E2C指南制修订、实施情况及我国相关要求,探讨我国定期汇总报告的现状、转化实施面临的问题和挑战,并提出相关建议。结果相对于《E2C（R1）：上市药品定期安全性更新报告（PSUR）》,《E2C（R2）：定期获益-风险评估报告（PBRER）》的内容更加全面和详细,更能反映产品获益和风险的整体情况。但采用PBRER也面临药品上市许可持有人（简称“持有人”）对PBRER的认知和理解欠佳、PBRER撰写需要更多专业人员参与、成熟产品获取完整数据困难等诸多挑战。结论全面采用PBRER有利于推动持有人进一步落实主体责任,也有利于国家和各省级药品不良反应监测机构对持有人相关工作的管理。建议以81号令的修订为契机,全面采用PBRER。

关键词: 国际人用药品注册技术协调会, 临床安全性数据管理, 定期安全更新报告, 定期获益-风险评估报告, 药品不良反应报告和监测管理办法, 监管, 药品不良反应, 药品上市许可持有人

Abstract: Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81.

Key words: ICH, E2C, PSUR, PBRER, Adverse Drug Reaction Reporting and Monitoring Management, supervision, adverse drug reactions, marketing authorization holder

中图分类号:

R951
R994.11

田春华, 吴桂芝. 定期获益-风险评估报告在我国的实施思考[J]. 中国药物警戒, 2023, 20(12): 1382-1384.

TIAN Chunhua, WU Guizhi. Implementation of periodic benefit risk evaluation reports in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1382-1384.

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