Ectd specification

ICH M2 EWG - International Council for Harmonisation of ...

ich ectd specification v 3.2. 2 16-july-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use

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Version 1.4.1 November 2011 - Europa

In line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format for administrative forms and product information

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EU Module 1 eCTD Specification - Europa

3 types, clarifications how to use new submission types and submission unit types. 2.4.1 29.09.2015 K. Menges Reconciliation of comments from public consultation.

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ICH M2 EWG

ich ectd stf specification v 2.6.1 3-june-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use

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eCTD v4.0運用に向けた企業での準備 - jpma.or.jp

• 通知の理解 – eCTD v4.0 国内実装ガイド – SSF（Specification for Submission Format ）の国内実装ガイド • ギャップ分析

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CTD: Revisions to the M4 Granularity Document

1/23/2017 2 3 Outline • Who is the CTD-Q IWG • Background • Objective of the Guideline Revision • Scope/Content of the Guideline Revision • Implementation of the Guideline Revision • Conclusion CTD: Revisions to the M4 Granularity Document 4 Background • 1994: o M2: “Electronic Standards for the Transfer of Regulatory Information” (ESTRI) EWG established

Provisional Translation (as of July 2015)

Provisional Translation (as of July 2015) * * This English version of the Japanese Notification is provided for reference purposes only. In the event of

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