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