News Archive

National implementation of EU eSubmission roadmap - information from UK MHRA and CZ SUKL


The EU eSubmission roadmap has already been adopted in November 2014 (see link here). One major objective of the eSubmission roadmap is to switch from paper to electronic format...[more]

Australian TGA releases final eCTD specification, revises NeeS format

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The Australian Therapeutic Goods Administration (TGA) has released the first final specification for the Australian eCTD.

Since late 2014 the TGA was accepting eCTD submissions...[more]

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]

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