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 |