ICHM多学科(Multidisciplinary Guidelines)

2024-04-20

多学科(Multidisciplinary Guidelines)


序号英文题目中文译文阶段发布时间是否有中文译稿
1M1 MedDRA Terminology 监管活动医学词典

MedDRA Points to Consider Companion DocumentMedDRA ® 数据检索和展示： 考虑要点
2018.06有
MedDRA Term Selection: Points to ConsiderMedDRA ® 术语选择： 考虑要点
2018.09.01有
MedDRA Best PracticesMedDRA ® 最佳规范
2018有
2M2 Electronic Standards 电子标准

M2：Electronic Standards for the Transfer of Regulatory Information Final Concept PaperM2：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 AbbreviationsM2：术语和缩略语词汇表
2015.6.11有
M2：File Format CriteriaM2：文件格式标准
2014.11.10有
Use of OIDs & UUIDs in ICH MessagesOID和UUID在ICH消息中的应用
2015.6.11有
3M3 Nonclinical Safety Studies 非临床研究

M3(R2) Questions and Answers (R2)M3(R2)问答 (R2)阶段52012.3.5有
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsM3(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52009.6.11有
4M4 : 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 UseM4（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52016.6.15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52004.6.10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52002.9.12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52003.7.17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52002.12.20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52003.11.11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52016.6.15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52004.6.10有
5M5 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
6M6 Gene Therapy 基因治疗

Final Concept Paper M6: Guideline on Virus and Gene Therapy Vector Shedding and TransmissionM6: 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 TransmissionM6: 病毒和基因治疗载体的脱落和传播 终版业务计划
2009.8.27
7M7 Genotoxic Impurities 遗传毒性杂质

M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskM7：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52014.6.23有
M7(R1): Addendum to M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskM7(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52017.3.31有
M7(R2)：Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic RiskM7（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52023.4.3有
M7(R2)：Questions and AnswersM7（R2）：问答文件阶段52022.5.24有
Addendum to M7(R2) ：Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable IntakesM7（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52023.4.3有
8M8 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 PaperM8: 电子通用技术文件 概念文件
2015.12.9
ICH M8 EWG/IWG Work PlanM8: 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 v1.2M8：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 v1.2M8：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 v1.2ICH eCTD v4.0 实施指南 v1.2
2016.11.10
eCTD v4.0 Implementation Package v1.2eCTD 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 RequirementsICH eCTD v4.0 要求


ICH M8 Expert Working Group Specification for Submission Formats for eCTDeCTD提交格式规范
2016.11.10
Change Control Process for the eCTDeCTD变更控制过程
2017.4
Request for change 请求变更表


9M9 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 BiowaiversM9：基于生物药剂学分类系统的生物等效性豁免阶段52019.11.20有
M9 Questions and AnswersM9问答文件阶段52019.11.20有
10M10 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 AnalysisM10：生物分析方法验证及样品分析阶段52022.05.24有
M10 Questions and Answers(Q&As)M10问答文件阶段52022.11.16有
M10 Frequently Asked Questions (FAQs)M10常见问题解答文件阶段52022.11.11有


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