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

附件：附件1：01.M2 Electronic Standards for the Transfer of Regulatory Information Final Concept Paper-英文原文.pdf
附件：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：附件3：02.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation - Procedure-英文原文.pdf
附件：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：附件5：03.Electronic Standards for the Transfer of Regulatory Information (ESTRI) General Recommendation- ESTRI Gateway-英文原文.pdf
附件：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：附件7：04.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – PDF-英文原文.pdf
附件：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：附件9：05.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML-英文原文.pdf
附件：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：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：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：附件13：07.Electronic Standards for the Transfer of Regulatory Information (ESTRI)File Format Recommendation – DOCX-英文原文.pdf
附件：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：附件15：08.Electronic Standards for the Transfer of Regulatory Information Controlled Vocabularies Recommendation - Genericode_英文原文.pdf
附件：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：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：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：附件19：10.Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Integrity – MD5-英文原文.pdf
附件：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：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：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：附件23：12.M2 Glossary of Terms and Abbreviations_英文原文.pdf
附件：附件24：12. M2 Glossary of Terms and Abbreviations_中文翻译公开征求意见稿.pdf
附件：附件25：13.ICH M2 File Format Criteria-英文原文.pdf
附件：附件26：13.ICH M2 File Format Criteria_中文翻译公开征求意见稿.pdf
附件：附件27：14.Use of OIDs & UUIDs in ICH Messages-英文原文.pdf
附件：附件28：14.Use of OIDs & UUIDs in ICH Messages_中文翻译公开征求意见稿.pdf