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 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 |
附件详情请点击阅读原文查看！
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