News Archive

EMA releases revision 48 of the Post-Authorisation Procedural Advice for Users of the CP

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A new revision 48 of the "Post-authorisation procedural advice for users of the centralised procedure" has been released by EMA this week.

The new revision now includes...[more]

New versions of electronic Application forms released

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New versions of the electronic application forms have been released. The update, dated 23 March 2015 concerns all forms available for human and veterinary products:

Initial MAA -...[more]

EMA releases new version of Formatted Table Template for Procedural Submission Cover Letters


The European Medicines Agency has released a new version of the formatted table template which is to be inserted in each procedural submission cover letter. The new version has...[more]

EMA updates information to PSUR repository, facing technical issues with some NAPs

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The European Medicines Agency has released new information related to the central PSUR Repository.

As part of the new information EMA announces that it will be mandatory to use...[more]

FDA updates Study Data Technical Conformance Guide

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The U.S. Food and Drug Administration has released a new version 2.1 of the "Study Data Technical Conformance Guide", dated March 2015.

The new version 2.1 takes into...[more]

EMA updates procedural advices for users of the Centralized Procedure

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EMA has released an update of the following procedural advice documents for users of the EU Centralized Procedure (Human Medicines):

Pre-authorisation procedural advice...[more]

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...[more]

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