2023年药品说明书和标签管理制度实施现状及完善研究报告

药品说明书和标签管理制度实施现状及完善研究 目录 研究摘要·································································1 前言······································································7 第一章 我国药品说明书和标签法律法规体系··························8 一、我国药品说明书和标签法律法规体系建设现状····································8 （一）法律法规 ·····························································8（二）部门规章 ·····························································9（三）规范性文件 ···························································9（四）指导性文件 ··························································10 二、中外说明书和标签法律法规体系建设情况比较···································13 （一）美国 ······························································13（二）欧盟 ······························································18（三）日本 ······························································19（四）中外比较 ····························································22 三、我国药品说明书和标签法律法规体系存在的问题································23 （一）法规规章修订滞后，未发挥衔接作用 ······································23（二）说明书和标签定义不明确，基本管理要求不清晰·····························23（三）指导性文件有待细化，特定产品不同人群说明书撰写要求缺少指导 ···············24 第二章 我国药品说明书和标签撰写、审批管理························25 一、我国药品说明书和标签撰写管理要求··········································25 （一）信息来源要求 ·······················································25（二）项目构成要求 ·······················································27（三）表述及格式要求 ·····················································31 二、我国药品说明书核准和变更管理要求·········································33 （一）说明书和标签管理机构 ················································33 （二）上市前核准程序 ·····················································33（三）上市后变更管理程序 ··················································34 三、中外药品说明书和标签撰写、审批管理要求比较··································35 （一）药品说明书和标签撰写管理要求比较 ·······································35（二）核准和变更管理要求比较 ···············································49 （一）药品说明书和标签审评管理部门设置与协作机制不完善 ···························59（二）患者说明书管理制度有待细化，说明书“看不懂”问题仍然存在 ····················59（三）仿制药说明书撰写要求不清晰，更新时限有待明确 ·····························60（四）药品说明书项目设置合理性有待加强 ·······································61（五）标签撰写要求不具体，与说明书关联性模糊 ··································61（六）药品名称尺寸要求不利于药品品牌建设 ·····································62（七）药品说明书变更管理实施期限不明确，持有人义务不清晰 ·······················62 第三章 我国药品说明书信息公开和电子说明书管理··················63 一、我国药品说明书信息公开管理要求···········································63 （一）法律依据 ··························································63（二）信息公开主体 ·······················································64（三）信息公开途径和内容 ··················································65 二、我国药品电子说明书实践情况··············································67 （一）药品监管部门监管要求 ················································67（二）第三方平台实践情况 ··················································68 三、中外药品说明书信息公开与电子说明书管理比较·································70 （一）信息公开平台 ·······················································70（二）信息公开主体和来源 ··················································72（三）信息公开内容 ·······················································73（四）信息公开形式 ·······················································77 四、我国药品说明书信息公开和电子说明书管理存在的问题·····························80 （一）缺乏统一的信息公开平台，平台建设主体和建设方式尚不确定 ·····················80（二）信息公开主体和公开形式尚无明确规定 ·····································80（三）电子说明书的推行存在较大挑战 ··········································80 第四章 我国药品说明书和标签管理体系完善建议······················81 （一）明确修订定位，形成管理性规范和技术指导文件相结合的法律法规体系 ···············81（二）明确药品说明书的概念，提升规定的可操作性 ·································81 二、完善技术指导原则体系，加强体系系统性与全面性·································82 （一）细化指导原则内容，提升针对性 ···········································82（二）规范新旧指导原则交替衔接，明确指南执行标准 ·······························82 三、健全行政管理体制，优化药品说明书和标签核准变更程序·····························82 （一）明确药品说明书和标签核准职责，建立分工和协作机制 ··························82（二）明确变更后过渡期限，优化实施程序 ········································83 四、优化内容和格式要求，提升规定的合理性和可操作性······························83 （一）确立说明书分类管理制度，保障临床合理用药 ································83（二）完善内容管理要求，提升说明书和标签信息的合理性 ···························84（三）明确格式管理要求，加强企业品牌建设 ·····································85 五、健全信息公开机制，提高说明书信息可及性····································85 （一）建立统一的信息公开平台，完善说明书上传和更新机制 ··························85（二）明确信息公开主体与公开形式，开放用药信息获取端口 ·························86（三）提高公众和企业对电子说明书的认知度 ·····································86（四）完善电子说明书法律体系，明确具体实施要求 ································87 研究摘要 一、研究目的 我国药品说明书和标签监管法律体系沿用已近二十年，药品说明书和标签的现有管理体系已明显与当前的药品监管、医药市场和公众健康的发展需求不相适应，对如何加强和完善我国说明书和标签监管体系的系统性研究，已成为保障用药安全核心命题。本研究通过梳理我国、美国、欧盟和日本药品说明书和标签管理制度，立足法律法规体系、撰写审批管理、信息公开和电子说明书管理等进行比较分析，为我国药品说明书和标签管理制度完善提供建议。 二、研究方法 本研究采用文献研究法、制度比较法、专家访谈法和问卷调查法。通过文献研究法，查阅梳理中欧美日的药品说明书和标签管理相关规定和要求；通过制度比较法，比较中美欧日药品说明书和标签法律体系和具体管理要求，分析制度特点；通过专家访谈法，发掘药品说明书与标签撰写、核准与变更工作的痛点，以及临床参考说明书用药指导时存在的实际问题；通过问卷调查法，收集企业对相关监管体系的评价和建议。 三、研究结果与结论 （一）我国药品说明书和标签管理制度 我国围绕药品说明书和标签管理初步建立了以《药品说明书和标签管理规定》（以下简称“24号令”）为核心的药品说明书法律体系，对药品说明书和标签内容格式撰写、核准变更管理等做出原则性基本要求，同时发布了 9 个规范性文件和 10 个技术指南进行详细指导（截至 2023 年