News Archiv

EMA releases updated versions of the pre-submission and post-authorisation procedural advices

The European Medicines Agency (EMA) has released updated versions of the

Pre-submission Procedural Advice EMA/339324/2007, and thePost-authorisation Procedural Advice...[more]

EU CMDh updates guidance documents for the submission of variations

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

CMDh starts voluntary pilot phase for technical eCTD validations to be performed by RMS on behalf of CMS

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has published a new guidance document (Doc. Ref.: CMDh/253/2012) detailing the...[more]

New draft version of technical EU eCTD/NeeS validation criteria released for consultation

The Telematics Implementation Group for electronic submissions (TIGes) has released new draft versions for public consultation of the EU technical validation criteria for eCTD...[more]

EMA informs stakeholders about reduced data requirements for XEVMPD

The European Medicines Agency informed stakeholders from the pharmaceutical industry about the proposed way forward to progress with the implementation of Article 57(2) of...[more]

CMDh releases new version of the cover template for new applications submitted through MRP/DCP

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants...[more]

EMA updates template for eCTD cover letters in the Centralized Procedure

The European Medicines Agency (EMA) has published a new version of their template for administrative information to be presented in eCTD cover letters within the EU Centralized...[more]