ICH指导原则 - 蒲标网

Multidisciplinary Guidelines
多学科综合

编号	阶段	内容
M1	Version 20.0	Medical Dictionary for Regulatory Activities(MedDRA ) 监管活动医学术语
M2		Electronic Standards for the Transfer of Regulatory Information(ESTRI) 监管信息传输电子标准
M3(R2)	Step 5	Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 药物进行人体临床试验和上市许可申请的非临床安全性研究指导原则
M3(R2) Q&As (R2)	Step 5	Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3的问与答
M4		The Common Technical Document(CTD) 通用技术文件
M4(R4)	Step 5	Organisation of the Common Technical Document For The Registration of Pharmaceuticals for human use 人用药物注册申请的通用技术文件组织结构
M4Q(R1)	Step 5	The Common Technical Document for the Registation of Pharmaceuticals for Human Use: Quality 人用药物注册申请的通用技术文件：质量
M4S(R2)	Step 5	The Common Technical Document for the Registration of Pharmaceuticals for human Use: Safety 人用药物注册申请的通用技术文件：安全性
M4E(R1)	Step 5	The Common Technical Document for the Registration of Pharmaceuticals for Human Use:Efficacy 人用药物注册申请的通用技术文件：有效性
M4E(R2)	Step 5	Revision of M4e Guideline on Enhancing the Format and Structure of Benefit-risk Information in Ich M4E指南修订，优化临床研究风险评估的格式与结构
M5		Data Elements and Standards for Drug Dictionaries 药物词汇的数据要素和标准
M6		Virus and Gene Therapy Vector Shedding and Transmission 病毒和基因治疗载体的脱落和传播
M7	Step 5	Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制
M7 Addendum	Step 3	M7 Addendum M7附录
M8	Step 4	Electronic Common Technical Document (eCTD) 电子通用技术文件
M9	Step 1	Biopharmaceutics Classification System-based Biowaivers 基于生物药剂学分类系统的生物豁免
M10	Step 1	Bioanalytical Method Validation 生物样品分析的方法验证

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