指导原则编号:
【 H 】 G C L 5 - 1 化学药品、治疗用生物制品说明书
指导原则
二○○四年十一月
目 录
一、概述 ························ 1 二、药品说明书格式与内容的一般要求 ··········· 1 三、说明书格式与内容的具体要求 ············· 4
（一）标题 ·································································· 4 （二）警示语 ······························································· 4 （三）药品名称 ···························································· 5 （四）成份 ·································································· 5 （五）性状 ·································································· 6 （六）处方组成 ···························································· 6 （七）适应症 ······························································· 6 （八）规格 ·································································· 7 （九）用法用量 ···························································· 7 （十）不良反应 ···························································· 8 （十一）禁忌 ······························································· 9 （十二）警告 ······························································· 9 （十三）注意事项 ······················································· 10 （十四）妊娠期及哺乳期妇女用药 ·································· 11 （十五）儿童用药 ······················································· 13 （十六）老年用药 ······················································· 14 （十七）药物相互作用 ················································· 16 （十八）药物过量 ······················································· 16
（十九）临床试验 ······················································· 17 （二十）药理毒理 ······················································· 17 （二十一）药代动力学 ················································· 18 （二十二）贮藏 ·························································· 18 （二十三）包装 ·························································· 18 （二十四）执行标准 ···················································· 18 （二十五）有效期 ······················································· 18 （二十六）批准文号 ···················································· 19 （二十七）生产企业 ···················································· 19 （二十八）参考文献 ···················································· 19 （二十九）说明书制定和修订时间 ·································· 20 四、参考文献 ····················· 20 五、附录 ······················· 20 六、著者 ······················· 23 化学药品、治疗用生物制品说明书指导原则起草说明 ···· 24
化学药品、治疗用生物制品说明书指导原则
一、概述
药品说明书是包含药学、药理学、药代动力学、毒理学、临床医学等有关药品安全性、有效性的重要科学数据、结论等信息，用以指导安全、正确、合理使用药品的技术性文件。药品生产企业应对药品说明书的正确性与准确性负责，并应当跟踪药品上市后的安全性、有效性的情况，必要时应当及时提出修改药品说明书的申请。
制定《化学药品、治疗用生物制品说明书指导原则》（以下简称本指导原则）的目的是为药品注册申请人或/和研究者提供合理思路，以利于撰写出结构完整、内容完善、供药品注册管理部门审核的药品说明书草案。同时，也为药品注册管理部门审核药品说明书提供技术参考。
本指导原则以国内相关规定提供的药品说明书项目为基本框架，借鉴发达国家药品监督管理部门制定的与说明书和标签相关的指导原则的成功经验，在充分考虑我国实际情况的基础上制定。
本原则详细列出了说明书的项目及格式，并对其内容的书写提出了要求。
二、药品说明书格式与内容的一般要求
在撰写、完善药品说明书或对药品说明书进行修订时，应基于以下总体考虑：
（一）说明书内容必须包括说明药品安全和有效的主要科学信
息。
（二）说明书内容必须具有知识性、真实性和准确性。 （三）说明书内容尽可能采用在人体获取的证据性数据。 （四）与人体安全有效用药密切相关的动物研究信息，经确认后与人体研究资料一同包含在说明书的相应部分。
（五）由于临床试验尚不可能完全暴露与药品临床应用相关的所有安全性和有效性信息，使药品说明书具有不完善的特性，因此药品说明书的完善、修订以及维护应成为经常性的工作。 （六）说明书应包括下列具体信息： 1、药品说明书标题 2、警示语 3、药品名称 通用名称 商品名称 英文名称 汉语拼音 4、成份 5、性状 6、处方组成 7、适应症 8、规格 9、用法用量
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化学药品、生物制品说明书指导原则
