06-02-2012

An short open consultation for updated versions of the technical criteria for TIGes is avalable here

09-01-2012

Publication of EU Module 1 Specification v1.4.1 is available can be viewed here

06-01-2012

The TIGes Vet FAQ document has been updated and can be found here

The TIGes Vet Change Control Tracking table has been updated and can be viewed here

05-01-2012

The Change Control Board Press release is available and can be viewed here

The EU Change Request Tracking table has been updated and can be viewed here

The Vet eSubmission Change Control Process has been updated and can be viewed here

28-11-2011

The BPG for the use of eCTD in MRP/DCP version 3.0 can be found here

23-11-2011

The European Medicines Agency announces plans to implement the eSubmission Gateway. The eSubmission Gateway will allow the electronic-only submission of all centralised procedure eCTD applications. All documentation can be found here

01-09-2011

TIGes Harmonised eCTD Guidance version 2.0 and release notes can be found here and The TIGes Harmonised NeeS guidance version 3.0 and release notes can be found here

31-08-2011

The final draft for the EU M1 specification can be found here

13-07-2011

The Clarification Concerning the New Validation Criteria for eCTD document has been updated and can be viewed here

21-06-2011

The updated documents on the EU Change Control Process can be found here

10-06-2011

Clarification concerning the new Validation Criteria for eCTD can be viewed here

31-05-2011

The eSubmission Gateway Status Report June 2011 is available and can be viewed here

16-05-2011

The EU eCTD Change Request/Q&A Tracking Table has been updated and can be found here