此页面上的内容需要较新版本的 Adobe Flash Player。

获取 Adobe Flash Player

当前位置:新闻中心>>工作动态>>通知公告>>新闻正文
关于公开征求《ICH M2:监管信息电子传输标准指导原则》中文翻译稿意见的通知
发布日期:20181130

       为推动ICH指导原则在中国转化实施,原国家食品药品监督管理总局信息中心作为《ICH M2:监管信息电子传输标准指导原则》的主办单位,组织翻译了14个ICH M2指导原则的文件(具体详见附件),现对这些中文翻译稿公开征求意见。
如有修改意见,请于2018年12月30日前将修改意见反馈至联系人电子邮箱:gkzhqyj@cde.org.cn
       附件:14个ICH M2指导原则文件清单
                                                                                                                                         ICH工作办公室
                                                                                                                                         2018年11月30日
附件
14个ICH M2指导原则文件清单

序号

英文原文名称

中文翻译公开征求意见稿名称

1

M2: Electronic Standards for the Transfer of Regulatory Information Final Concept Paper_英文原文

M2: Electronic Standards for the Transfer of Regulatory Information Final Concept Paper_中文翻译公开征求意见稿

2

Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure_中文翻译公开征求意见稿

3

Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation ESTRI Gateway_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation ESTRI Gateway_中文翻译公开征求意见稿

4

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation PDF_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation PDF_中文翻译公开征求意见稿

5

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation XML_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation XML_中文翻译公开征求意见稿

6

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation PDF/A_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation PDF/A_中文翻译公开征求意见稿

7

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation DOCX_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation DOCX_中文翻译公开征求意见稿

8

Electronic Standards for the Transfer of Regulatory Information (ESTRI) Controlled Vocabularies Recommendation - Genericode_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) Controlled Vocabularies Recommendation - Genericode_中文翻译公开征求意见稿

9

Electronic Standards for the Transfer of Regulatory Information (ESTRI) Information Transfer Recommendation EDIINT_V3_0_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) Information Transfer Recommendation EDIINT_V3_0_中文翻译公开征求意见稿

10

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity MD5_英文原文

Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity MD5_中文翻译公开征求意见稿

11

Electronic Standards for the Transfer of Regulatory Informaation (ESTRI) File Integrity Recommendation - SHA-256_英文原文

Electronic Standards for the Transfer of Regulatory Informaation (ESTRI) File Integrity Recommendation - SHA-256_中文翻译公开征求意见稿

12

M2 Glossary of Terms and Abbreviations_英文原文

M2 Glossary of Terms and Abbreviations_中文翻译公开征求意见稿

13

ICH M2 File Format Criteria_英文原文

ICH M2 File Format Criteria_中文翻译公开征求意见稿

14

Use of OIDs & UUIDs in ICH Messages_英文原文

Use of OIDs & UUIDs in ICH Messages_中文翻译公开征求意见稿

附件 1 : 01.M2 Electronic Standards for the Transfer of Regulatory Information Final Concept Paper-英文原文.pdf
附件 2 : 01.M2 Electronic Standards for the Transfer of Regulatory Information Final Concept Paper_中文翻译公开征求意见稿.pdf
附件 3 : 02.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure-英文原文.pdf
附件 4 : 02.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure_中文翻译公开征求意见稿.pdf
附件 5 : 03.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation- ESTRI Gateway-英文原文.pdf
附件 6 : 03.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation-ESTRI Gateway_中文翻译公开征求意见稿.pdf
附件 7 : 04.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF-英文原文.pdf
附件 8 : 04.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF_中文翻译公开征求意见稿.pdf
附件 9 : 05.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML-英文原文.pdf
附件 10 : 05.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML_中文翻译公开征求意见稿.pdf
附件 11 : 06.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF A-英文原文.pdf
附件 12 : 06.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF A_中文翻译公开征求意见稿.pdf
附件 13 : 07.Electronic Standards for the Transfer of Regulatory Information (ESTRI)File Format Recommendation – DOCX-英文原文.pdf
附件 14 : 07.Electronic Standards for the Transfer of Regulatory Information (ESTRI)File Format Recommendation – DOCX_中文翻译公开征求意见稿.pdf
附件 15 : 08.Electronic Standards for the Transfer of Regulatory Information Controlled Vocabularies Recommendation - Genericode_英文原文.pdf
附件 16 : 08.Electronic Standards for the Transfer of Regulatory Information Controlled Vocabularies Recommendation - Genericode_中文翻译公开征求意见稿.pdf
附件 17 : 09.Electronic Standards for the Transfer of Regulatory Information Information Transfer Recommendation – EDIINT_V3_0_英文原文.pdf
附件 18 : 09.Electronic Standards for the Transfer of Regulatory Information Information Transfer Recommendation – EDIINT_V3_0_中文翻译公开征求意见稿.pdf
附件 19 : 10.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity – MD5-英文原文.pdf
附件 20 : 10.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity – MD5_中文翻译公开征求意见稿.pdf
附件 21 : 11.Electronic Standards for the Transfer of Regulatory Informaation (ESTRI) File Integrity Recommendation - SHA-256-英文原文.pdf
附件 22 : 11.Electronic Standards for the Transfer of Regulatory Informaation (ESTRI) File Integrity Recommendation - SHA-256_中文翻译公开征求意见稿.pdf
附件 23 : 12.M2 Glossary of Terms and Abbreviations_英文原文.pdf
附件 24 : 12. M2 Glossary of Terms and Abbreviations_中文翻译公开征求意见稿.pdf
附件 25 : 13.ICH M2 File Format Criteria-英文原文.pdf
附件 26 : 13.ICH M2 File Format Criteria_中文翻译公开征求意见稿.pdf
附件 27 : 14.Use of OIDs & UUIDs in ICH Messages-英文原文.pdf
附件 28 : 14.Use of OIDs & UUIDs in ICH Messages_中文翻译公开征求意见稿.pdf
相关新闻
关于公开征求ICH非临床安全性指导原则中文翻译稿意见的通知 20181130
关于公开征求ICH指导原则《S11:支持儿科用药开发的非临床安全性评价》意见的通知 20181031
药审中心召开ICH Q8-Q11专题研讨会 20180926
关于公开征求《ICH M4人用药品注册通用技术文档》中文翻译稿意见的通知 20180926
关于公开征求《ICH E2F:药物研发期间安全性更新报告指导原则》中文翻译稿意见的通知 20180918
关于公开征求6个ICH指导原则中文翻译稿意见的通知 20180918
药审中心召开ICH安全性指导原则(Safety Guidelines)和有效性指导原则(Efficacy Guidelines)转化实施专家研讨会 20180918
关于公开征求ICH指导原则《M9:基于生物药剂学分类系统的生物等效性豁免》意见的通知 20180905
关于开通“ICH工作办公室专栏”的通知 20180803
关于公开征求ICH指导原则《Q3D(R1):元素杂质指导原则》意见的通知 20180706
加快ICH E2B落地实施 药审中心召开座谈会 20180606
ICH《E2B(R3)临床安全数据的管理:个例安全报告传输的数据元素》研讨与培训会成功举办 20180605
关于公开征求ICH指导原则《Q12:产品生命周期管理的技术和法规考虑》意见的通知 20180511
ICH监管活动医学词典研讨与培训会成功举办 20180420
关于2018年上半年ICH指导原则培训的通知 20180328
Copyright © 国家食品药品监督管理总局药品审评中心    All Right Reserved. 
地址: 中国  北京市朝阳区建国路128号     邮编:100022    
总机:8610-68585566     传真:8610-68584189    备案序号:京ICP备09013725号