16.03.2015

Start of the eCTD Version 4 EU M1 Implementation Guide Public Consultation

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The EU eSubmission Change Management Board (CMB) has announced the start of the public consultation period for the eCTD 4.0 EU Module 1 Implementation Guide.

Stakeholders from pharmaceutical industry, software vendors and regulatory agencies are invited to send their comments by May 22, 2015 to eCTD4consultation@ema.europa.eu using the comment sheet provided (see below)

The implementation guide together with the EU M1 controlled vocabularies and a template sheet to collect comments are available for download from EMA eSubmission website (see links at the bottom of this article).

[Source: eSubmission CMB]

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