化学药品、生物制品说明书指导原则

【H】GCL5-1指导原则编号：化学药品、生物制品说明书指导原则（第二稿）二00四年三月一日1目录一．概述························4二．药品说明书形式与内容的一般要求···········4三．说明书形式与内容的具体要求·············8（一）标题························································································8（二）警示语····················································································8（三）药品名称·················································································8（四）成份························································································9（五）性状························································································9（六）处方组成·················································································9（七）药理毒理·················································································9（八）药代动力学···········································································10（九）临床研究···············································································11（十）适应证··················································································11（十一）用法用量···········································································12（十二）不良反应···········································································13（十三）禁忌··················································································14（十四）警告··················································································15（十五）注意事项···········································································16（十六）妊娠期妇女及哺乳期妇女用药·······································17（十七）儿童用药···········································································19（十八）老年患者用药···································································202（十九）药物相互作用···································································21（二十）药物过量···········································································22（二十一）规格···············································································22（二十二）贮藏···············································································22（二十三）包装···············································································23（二十四）有效期···········································································23（二十五）批准文号·······································································23（二十六）生产企业·······································································23（二十七）参考文献·······································································24（二十八）说明书制定和修订时间···············································24四．参考文献·····················24五．附录·······················25六．起草说明·····················28七.著者························333一．概述药品说明书是由申办人和生产企业撰写的、提供给医生和患者的与药物应用相关的所有重要信息的文书，主要包括药品的安全性和有效性两个方面的内容。药品生产企业应当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。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，借鉴先进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，在充分考虑我国制药行业实际的基础上制定。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。本原则制定的目的拟为申办人和生产企业、专家和药政管理人员提供可供交流的平台，启动《化学药品、生物制品说明书指导原则》的制定、完善、确定以及试行后的修订工作程序；以使本草案能成为制定和维护药品说明书的指导性文件。二．药品说明书形式与内容的一般要求药品说明书为指导医生和患者合理用药的法规性文件，药品生产企业应当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。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4以下总体考虑：（一）说明书内容必须包括用于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，在任何项目中不得在语气上有宣传性，更不能虚假和误导。不能没有证据地扩大有效性，也不能回避负面信息。（三）说明书内容尽可能以来源于药品人体应用的客观证据性数据为依据，如果安全性或有效性方面的证据不充分或缺乏，不应在临床应用方面提供暗示性建议。（四）根据动物研究资料得出的对人体安全有效用药必需的结论应予确认，并与人体研究资料一同包含在说明书的相应部分。（五）由于临床研究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、修订以及维护应成经常性的工作。（六）说明书应包括下列具体信息，具体项目按如下顺序排列：1．药品说明书标题2．警示语3．药品名称通用名称汉语拼音英文名称商品名54．成份5．性状6．处方组成7．药理毒理8．人体药代动力学9．临床研究10．适应证11．用法用量12．不良反应13．禁忌14．警告15．注意事项16．妊娠期妇女及哺乳期妇女用药17．儿童用药18．老年患者用药19．药物相互作用20．药物过量21．规格22．贮藏23．包装24．有效期25．批准文号626．生产企业企业名称：生产地址：邮政编码：电话和传真号码：须标明国内区号。网址或电子信箱：27．参考文献28．说明书制定和修订日期（七）如果说明书中某些项目不适宜，可以省略。如：用于老年疾病药物说明书中的儿童用药项。（八）说明书应包括制定和各次修订的日期，放置在说明书最后一项之后的显著位置。（九）说明书中的疾病名称、临床检验方法和结果、药学专业名词、药品名称以及度量衡单位等均须采用国家颁布的名词，请参阅全国自然科学名词审定委员会最新公布的《医学名词》（各分册）及《药学名词》（科学出版社出版）、《中国药品通用名称》（药典委员会编，化学工业出版社出版，1997）和中华人民共和国国家标准《国际单位制及其应用》（技术标准出版社出版）。（十）说明书的文字必须规范、准确、简练、通顺。7三．说明书形式与内容的具体要求（一）标题“XXX说明书”中的“XXX”是指该药品的通用名称。（二）警示语警示语为警告项内容的浓缩。是对药品严重不良反应及潜在的安全性问题的警告，可以包括药品禁忌、注意事项及剂量过量等需提示用药人群特别注意的事项。如有该方面的内容，应当在说明书标题下以醒目的黑体字注明，并以黑框圈示。（三）药品名称1．通用名称；汉语拼音；英文名称：通用名称系指列入国家药品标准的中文名称。如该药品属《中华人民共和国药典》（以下简称“药典”）收载的品种，其通用名称、汉语拼音及英文名须与药典一致；非药典收载的品种，其通用名称须采用《中国药品通用名称》所规定的名称,其剂型名称应与药典一致；如拟采用的通用名属我国首次使用，需经国家药典委员会核定。2．商品名：是指经国家药品监督管理部门批准的特定企业使用的药品名称，不使用商品名称的药品不列此项。8（四）成份单一成份的制剂须列其化学名称、化学结构式、分子式、分子量，列出的化学名称、化学结构式、分子式、分子量须与国家药品标准一致。复方制剂可免写化学名称化学结构式、分子式、分子量内容，表达为“本品为复方制剂，其组分为：…（各组份的通用名称）”。组份按一个单位（如每片、胶囊、包、安瓿、支、瓶等）列出所含的活性成份及量。（五）性状按国家药品标准性状项内容书写。（六）处方组成列出处方组成，包括辅料。（七）药理毒理包括药理作用和毒理研究两部分内容：药理作用为临床药理中药物对人体作用的有关信息，如与已明确的临床疗效有关或有助于阐述临床药理作用时，也可以包括体外试验和（或）动物试验的结果。药理作用的内容包括药物类别、药理活性（临床药理）、作用机制等，复方制剂的药理作用可以为每一组成成份的药理作用。9毒理研究所涉及的毒理研究内容是指与临床应用相关，有助于判断药物临床安全性的非临床毒理研究结果。应当描述动物种属类型，给药方法（剂量、给药周期、给药途径）和主要毒性表现等重要信息。一般包括致癌性、遗传毒性、长期毒性等内容。必要时应当包括急性毒性、依赖性、一般药理及其他与给药途径相关的特殊毒性研究等信息。复方制剂的毒理研究内容应当尽量包括复方给药的毒理研究结果，若无该信息，应当写入单药的相关毒理内容。非处方药可以不列该项。（八）药代动力学药代动力学信息对于说明药物的安全性和有效性非常重要。尽可能详细描述药物的吸收、分布、代谢和排泄