Question

https://sourceforge.net/projects/ectdindexer/        一个开源程序，用于生成以eCTD格式提交药品注册档案所需的xml骨干eu-regional.xml和index.xml。

Last Update: 2016-11-19

Download n open source program to generate the xml backbones eu-regional.xml and index.xml required for submission of registration dossiers for pharmaceuticals in the eCTD format.

Features

• EU M1 v. 2.0 (from 2013-04-03)
• Runs under Mono in Linux   

eCTD indexer 

Comments

https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-industry-biotechnological-biological-biotech-products.html

Answer 1

16-09-2019

http://esubmission.ema.europa.eu/eCTD%20NMV/eCTD.html   

Comments

eCTD Version 4.0

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Electronic Common Technical Document (eCTD)  https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

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台湾的
https://www.cde.org.tw/Content/Files/Knowledge/bf1290af-acd0-4729-bd4b-828f900a0e38.pdf

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ICH
https://ich.org/page/ich-electronic-common-technical-document-ectd-v40

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瑞士
https://www.swissmedic.ch/swissmedic/en/home/services/submissions/ectd.html

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加拿大
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd.html

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奥地利
https://www.bfarm.de/EN/Drugs/licensing/ZulRelThemen/eSubmission/eSubmission-eCTD.html

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澳大利亚
https://www.tga.gov.au/australian-ectd-submissions