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]

EU eCTD Module 1 specification version 1.4.1 released

The final version 1.4.1 of the EU eCTD Module 1 specification have been released by EMA. The new version which has the version date "November 2011" incorporates the...[more]

Updates regarding EU Change Request Tracking table and Change Control Processes

A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes. The new version 1.28 of the Tracking Table contains changes from the...[more]

CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the...[more]