Multidisciplinary Guidelines
多学科综合
编号阶段内容
M1Version 20.0Medical Dictionary for Regulatory Activities(MedDRA )
监管活动医学术语
M2Electronic Standards for the Transfer of Regulatory Information(ESTRI)
监管信息传输电子标准
M3(R2)Step 5Guidance 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 5Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
M3的问与答
M4The Common Technical Document(CTD)
通用技术文件
M4(R4)Step 5Organisation 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 5The 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 5The 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 5The 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 5Revision 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
M5Data Elements and Standards for Drug Dictionaries
药物词汇的数据要素和标准
M6Virus and Gene Therapy Vector Shedding and Transmission
病毒和基因治疗载体的脱落和传播
M7Step 5Assessment 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 AddendumStep 3M7 Addendum
M7附录
M8Step 4Electronic Common Technical Document (eCTD)
电子通用技术文件
M9Step 1Biopharmaceutics Classification System-based Biowaivers
基于生物药剂学分类系统的生物豁免
M10Step 1Bioanalytical Method Validation
生物样品分析的方法验证
 
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