| 序号 |
英文题目 |
中文译文 |
阶段 |
发布时间 |
是否有中文译稿 |
| 1 |
M1 MedDRA Terminology 监管活动医学词典 |
|
MedDRA Points to Consider Companion Document |
MedDRA ® 数据检索和展示： 考虑要点 |
|
2018.06 |
有 |
| MedDRA Term Selection: Points to Consider |
MedDRA ® 术语选择： 考虑要点 |
|
2018.09.01 |
有 |
| MedDRA Best Practices |
MedDRA ® 最佳规范 |
|
2018 |
有 |
| 2 |
M2 Electronic Standards 电子标准 |
|
M2：Electronic Standards for the Transfer of Regulatory Information Final Concept Paper |
M2：监管信息电子传输标准 最终概念文件 |
|
1994.10.27 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure |
监管信息电子传输标准 一般性建议-程序 |
|
2015.6.11 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI)-Gateway |
监管信息电子传输标准 一般性建议-ESTRI网关 |
|
2015.6.11 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF |
监管信息电子传输标准 文件格式建议-PDF |
|
2011.4.5 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML |
监管信息电子传输标准 文件格式建议-XML |
|
2005.11.10 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF/A |
监管信息电子传输标准 文件格式建议-PDF/A |
|
2014.6.2 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI)File Format Recommendation – DOCX |
监管信息电子传输标准 文件格式建议-DOCX |
|
2015.6.11 |
有 |
| Electronic Standards for the Transfer of Regulatory Information Controlled Vocabularies Recommendation - Genericode |
监管信息电子传输标准 受控词汇建议-通用编码 |
|
2015.6.11 |
有 |
| Electronic Standards for the Transfer of Regulatory Information Information Transfer Recommendation – EDIINT V3.0 |
监管信息电子传输标准 信息传输建议-EDIINT V3.0 |
|
2018.6.7 |
有 |
| Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity – MD5 |
监管信息电子传输标准 文件完整性-MD5 |
|
2010.6.10 |
有 |
| Electronic Standards for the Transfer of Regulatory Informaation (ESTRI) File Integrity Recommendation - SHA-256 |
监管信息电子传输标准 文件完整性建议-SHA-256 |
|
2015.6.11 |
有 |
| M2：Glossary of Terms and Abbreviations |
M2：术语和缩略语词汇表 |
|
2015.6.11 |
有 |
| M2：File Format Criteria |
M2：文件格式标准 |
|
2014.11.10 |
有 |
| Use of OIDs & UUIDs in ICH Messages |
OID和UUID在ICH消息中的应用 |
|
2015.6.11 |
有 |
| 3 |
M3 Nonclinical Safety Studies 非临床研究 |
|
M3(R2) Questions and Answers (R2) |
M3（R2）问答（R2）文件 |
阶段5 |
2012.3.5 |
有 |
| M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
M3（R2）：支持药物进行临床试验和上市的非临床安全性研究指导原则 |
阶段5 |
2009.6.11 |
有 |
| 4 |
M4 : The Common Technical Document 通用技术文件 |
|
M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use |
M4（R4）：人用药物注册通用技术文档的组织（中文版：征求意见稿） |
阶段5 |
2016.6.15 |
有 |
| M4 Implementation Working Group Questions & Answers (R3) |
M4执行工作组问答（R3）（中文版：征求意见稿） |
阶段5 |
2004.6.10 |
有 |
| The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1) |
M4Q（R1）：人用药物注册通用技术文档：药学部分（中文版：征求意见稿） |
阶段5 |
2002.9.12 |
有 |
| M4Q Implementation Working Group Questions & Answers (R1) |
M4Q执行工作组问答（R1）（中文版：征求意见稿） |
阶段5 |
2003.7.17 |
有 |
| The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety – M4S(R2) |
M4S（R2）：人用药物注册通用技术文档：安全性部分（中文版：征求意见稿） |
阶段5 |
2002.12.20 |
有 |
| M4S Implementation Working Group Questions & Answers (R4) |
M4S执行工作组问答 （R4）（中文版：征求意见稿） |
阶段5 |
2003.11.11 |
有 |
| Efficacy- M4E(R2) |
M4E（R2）：人用药物注册通用技术文档：有效性部分（中文版：征求意见稿） |
阶段5 |
2016.6.15 |
有 |
| M4E Implementation Working Group Questions & Answers (R4) |
M4E执行工作组问答（R4）（中文版：征求意见稿） |
阶段5 |
2004.6.10 |
有 |
| 5 |
M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准 |
|
The Re-development of the Standard for E2B(R3) and the Development of Standards for the Identification of Medicinal Products (IDMP)(ICH M5) |
ICH M5: E2B(R3)标准的再制定及医药产品鉴定标准的制定 |
|
2010.11.1 |
|
| ICH E2B(R3) Implementation Working Group ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) |
E2B(R3)实施工作组 个例病例安全报告的电子传输 问答部分 |
2.0版本 |
2016.11.10 |
|
| Appendix I (B) to the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) |
个例病例安全报告的电子传输实施指南附录 I (B) |
2.02版本 |
2016.11.10 |
|
| Appendix I (G) to the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) |
个例病例安全报告的电子传输实施指南附录 I (G) |
1.02版本 |
2016.11.10 |
|
| Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) |
个例病例安全报告的电子传输实施指南 |
5.02版本 |
2016.11.10 |
|
| 6 |
M6 Gene Therapy 基因治疗 |
|
Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission |
M6: 病毒和基因治疗载体的脱落和传播 终版概念文件 |
|
2009.8.26 |
|
| General Principles to Address Virus and Vector Shedding |
解决病毒和基因治疗载体脱落的基本原则 |
|
2009.6 |
|
| An inventory of shedding data from clinical gene therapy trials |
临床基因疗法试验脱落数据目录 |
|
2007.7.30 |
|
| Final Business Plan M6: Guideline on Virus and Gene Therapy Vector Shedding and Transmission |
M6: 病毒和基因治疗载体的脱落和传播 终版业务计划 |
|
2009.8.27 |
|
| 7 |
M7 Genotoxic Impurities 遗传毒性杂质 |
|
M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
M7：评估和控制药物中的DNA活性（致突变）杂质以限制潜在的致癌风险 |
阶段5 |
2014.6.23 |
有 |
| M7(R1): Addendum to M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
M7（R1）：评估和控制药物中DNA反应性（致突变）杂质以限制潜在致癌风险 |
阶段5 |
2017.3.31 |
有 |
| M7(R2)：Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
M7（R2）：评估和控制药物中DNA反应性（致突变）杂质以限制潜在致癌风险 |
阶段5 |
2023.4.3 |
有 |
| M7(R2)：Questions and Answers |
M7（R2）：问答文件 |
阶段5 |
2022.5.24 |
有 |
| Addendum to M7(R2) ：Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes |
M7（R2）附录：ICH M7原则在化合物可接受摄入量计算中的应用 |
阶段5 |
2023.4.3 |
有 |
| 8 |
M8 Electronic Common Technical Document (eCTD) 电子通用技术文件 |
|
Electronic Common Technical Document Specification V3.2.2 |
电子通用技术文件规范 V3.2.2 |
|
2008.7.16 |
|
| M8 : Electronic Common Technical Document Concept Paper |
M8: 电子通用技术文件 概念文件 |
|
2015.12.9 |
|
| ICH M8 EWG/IWG Work Plan |
M8: 电子通用技术文件 工作计划 |
|
2017.3.13 |
|
| Support Documentation for M8: eCTD EWG eCTD v4.0 Implementation Package v1.2 |
M8：eCTD专家工作组eCTD v4.0实施包 v1.2 支持性证明文件 |
|
2016.11 |
|
| Orientation Material forM8: eCTD EWG eCTD v4.0 Implementation Package v1.2 |
M8：eCTD专家工作组eCTD v4.0实施包 v1.2 培训材料 |
|
2016.11 |
|
| ICH Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.2 |
ICH eCTD v4.0 实施指南 v1.2 |
|
2016.11.10 |
|
| eCTD v4.0 Implementation Package v1.2 |
eCTD v4.0 实施包 v1.2 |
|
|
|
| USFDA eCTD v4.0 Implementation Package History v1.1 |
美国FDA eCTD v4.0 实施包历史 v1.1 |
|
|
|
| USFDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.1 |
美国FDA 模块1 eCTD v4.0 实施指南 v1.1 |
|
2017.2.20 |
|
| ICH eCTD v4.0 Requirements |
ICH eCTD v4.0 要求 |
|
|
|
| ICH M8 Expert Working Group Specification for Submission Formats for eCTD |
eCTD提交格式规范 |
|
2016.11.10 |
|
| Change Control Process for the eCTD |
eCTD变更控制过程 |
|
2017.4 |
|
| Request for change |
请求变更表 |
|
|
|
| 9 |
M9 Biopharmaceutics Classification System-based Biowaivers 基于生物药剂学分类系统的生物豁免 |
|
M9: Biopharmaceutics Classification System-based Biowaivers |
M9：基于生物药剂学分类系统的生物等效性豁免 |
阶段5 |
2019.11.20 |
有 |
| M9 Questions and Answers |
M9问答文件 |
阶段5 |
2019.11.20 |
有 |
| 10 |
M10 Bioanalytical Method Validation and Study Sample Analysis 生物分析方法验证及样品分析 |
|
M10 Bioanalytical Method Validation and Study Sample Analysis |
M10：生物分析方法验证及样品分析 |
阶段5 |
2022.05.24 |
有 |
| M10 Questions and Answers(Q&As) |
M10问答文件 |
阶段5 |
2022.11.16 |
有 |
| M10 Frequently Asked Questions (FAQs) |
M10常见问题解答文件 |
阶段5 |
2022.11.11 |
有 |
| 11 |
M12 Drug Interaction Studies |
|
M12:Drug Interaction Studies |
M12：药物相互作用研究 |
阶段5 |
2024.5.21 |
有 |
| M12:Drug Interaction Studies Q&A |
M12：药物相互作用研究问答文件 |
阶段5 |
2024.5.21 |
有 |
| 12 |
M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms 口服固体速释制剂的生物等效性 |
|
M13A：Bioequivalence for Immediate-Release Solid Oral Dosage Forms |
M13A：口服固体速释制剂的生物等效性 |
阶段5 |
2024.7.23 |
有 |
| M13A Questions and Answers |
M13A问答文件 |
阶段5 |
2024.7.23 |
有 |
| 13 |
M14 Use of real-world data for safety assessment of medicines 使用真实世界数据进行药品安全性评估 |
|
M14：General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines |
M14：使用真实世界数据进行药品安全性评估的非干预性研究：规划、设计、分析和报告的一般原则 |
阶段5 |
2025.9.4 |
有 |
