News Archiv

EMA releases another update of the CHMP dossier requirements

The European Medicines Agency (EMA) has released another update of the "Dossier requirements for Members of the Committee for medicinal products for human use (CHMP)"....[more]

EMA announces full availability of electronic application forms; udpated eSubmission gateway Q&A

After succesfully completing the previous pilot phase, the European Medicines Agency (EMA) has recently announced the full availability of the electronic application forms for...[more]

EMA updates Post-authorisation procedural advice and CHMP dossier requirements

The European Medicines Agency (EMA) has released another update of the "Post-Authorisation Procedural Advice" for users of the EU  Centralized Procedure. The new...[more]

EU eCTD Change Request/Q&A tracking table updated by TIGes

The Telematics Implementation Group - electronic submissions (TIGes) has released another updated version 1.30 of the EU eCTD Change Request/Q&A Tracking ...[more]

TIGes announces start of the eCTD Version 4 feasibility test

The Telematics Implementation Group for electronic submissions (TIGes) has announced the start of the eCTD Version 4 feasibility test. Prior to that it was decided that the...[more]

EMA announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements

The European Medicines Agency (EMA) has announced next steps for the maintanance of information on medicines in accordance with mandatory Article 57(2) requirements. On 28 June...[more]

CMDh releases updated guidance documents regarding submission of variations

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released some updated guidance regarding the submission of variations in accordance...[more]