中国附条件批准药品说明书编制与管理

Preparation and management of conditional approval drug package inserts in China

摘要

目的: 为加强中国附条件批准药品说明书的编制与管理、提升说明书对临床合理用药的指导价值提供建议与参考。方法: 综合运用政策法规梳理、现状与问题分析、国际经验借鉴等方法,系统梳理中国附条件批准药品说明书的相关政策法规,深入剖析当前该类药品说明书在撰写规范、信息更新、传递效率等方面存在的核心问题,再对比借鉴美国与欧盟体系的成熟经验,进而形成我国加强该类药品说明书管理的具体建议。结果: 通过上述研究,明确了我国附条件批准药品说明书在法规政策体系、信息更新与传递机制上的短板及可借鉴的国际经验,提出了涵盖专项技术规范、更新约束机制、信息传递体系、数字化监管平台的系统性解决方案。结论: 通过完善附条件批准药品说明书的编制与管理机制,能够有效应对该类药品的证据局限性,提升说明书对临床用药的指导价值,为保障患者用药安全与提高治疗有效性提供有力支撑,推动附条件批准药品全生命周期管理水平的提升,同时助力我国药品审评审批制度改革深化与医药产业高质量发展。

Abstract

Objective: To provide suggestions and references for strengthening the preparation and management of labeling for conditionally approved drugs in China and for enhancing their guiding value for rational clinical drug use. Methods: A comprehensive approach integrating policy and regulation review, current situation and problem analysis, and international experience reference was adopted. We systematically reviewed the relevant policies and regulations on labeling for conditionally approved drugs in China, conducted an in-depth analysis of the core problems existing in the writing specifications, information updates and communiation efficiency of such labeling, and then formulated specific recommendations for improving the management of labeling for conditionally approved drugs in China by drawing on the mature experience of the United States and the European Union systems. Results: Through the above research, we identified the gaps in China's regulatory policy system and in the information update and communication mechanisms for labeling of conditionally approved drugs, as well as international experience that can be used for reference, and proposed systematic solutions covering dedicated technical specifications, update constraint mechanisms, information communication systems and digital regulatory platforms. Conclusion: By improving the preparation and management mechanism of labeling for conditionally approved drugs, we can effectively address the evidence limitations of such drugs, enhance the guiding value of labeling for clinical drug use, provide strong support for ensuring patient medication safety and improving treatment effectiveness, promote the improvement of the lifecycle management level of conditionally approved drugs, and at the same time facilitate the deepening of the reform of China's drug review and approval system and the high-quality development of the pharmaceutical industry.

关键词

附条件批准 / 药品说明书 / 政策法规 / 国际经验

Key words

conditional approval / drug instructions / policies and regulations / international experience

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基金资助

辽宁省教育厅基本科研资助项目(LJ142510163002)