19-11-2012
The EMA are working on improvements to the eSubmission Gateway and the next release is expected early in 2013. One of the main features of the next release will be the automated acknowledgement confirming the technical compliance of eCTD submissions. The User Acceptance Testing for the new Web Client will commence on Monday 19th November and finish on Friday 30th November 2012. It is expected that the Web Client will be available in the production (live) environment early in 2013. For more information, click here
31-10-2012
New versions of the electronic application forms for Initial Marketing Authorisation Application (Human), Initial Marketing Authorisation Application (Vet), Renewal and Variations have been released. This release implements revision 10 of the Renewal form and also fixes a number of defects that existed in previous versions of the forms. The new forms and release notes can be found here
16-10-2012
The EU Change Request Tracking table has been updated and can be viewed here
28-09-2012
The EMA would like to invite applicants to participate in User Acceptance Testing (UAT) for the new web client solution of the eSubmission Gateway. The eSubmission Gateway is currently used to send Centralised Procedure eCTD submissions to the EMA instead of sending CDs/DVDs via mail. The web client is a free web based tool which is mainly aimed for applicants with low transmission volumes, such as SMEs.
Companies interested in participating are required to submit the UAT participation form available here by email to natasha.brown@ext.ema.europa.eu by 8th October 2012
31-08-2012
New versions of the electronic application forms for Initial Marketing Authorisation Application (Human), Initial Marketing Authorisation Application (Vet), Renewal and Variations have been released. This hotfix release addresses a number of urgent issues (please refer to the release notes of each form for details). The new forms and release notes can be found here
20-08-2012
The EMA eSubmission Gateway Question and Answer document has been updated and can be found here
27-07-2012
The eAF project has reached the end of the pilot and is now considered to be in production. Read the full announcement here
The TIGes Harmonisation group invited all vendors and other interested parties to a Validation Webinar on Friday 13 July 2012 to explain the changes in the new major versions of the EU validation criteria that will come into force the 1 December 2012. The slides that were presented at the Webinar and the Q&As raised in relation to the validation criteria are available here
19-07-2012
The EU Change Request Tracking table has been updated and can be viewed here
16-07-2012
New versions of the Electronic Application Forms for MAA-Human, MAA-Vet, Renewals and Variations have been released according to a scheduled release plan. The updated versions of the forms can be found here
eCTD NMV/RPS is now called eCTD version 4.0. More information can be found here
The EMA Gateway Question and Answer document has been updated and can be found here
29-06-2012
A Validation Webinarn will be held Friday July 13. More information can be found here
26-06-2012
The TIGes Vet Terms of Reference has been updated and can be found here
The TIGes Vet roadmap has been updated and can be found here
22-06-2012
The EMA Gateway Question and Answers document has been updated and can be found here
18-06 -2012
A hotfix of the Electronic Application Forms for MAA-Human, MAA-Vet and Renewal has been released to resolve two critical defects and can be found here
06-05-2012
The EU Change Request Tracking table has been updated and can be viewed here
19-04-2012
The European Medicines Agency are pleased to announce that the eSubmission Gateway for electronic submissions is in full production. The related documents can be found here
03-04-2012
Electronic Application Form for Variations (v1.2.24) has been updated and can be found here
15-03-2012
The EMA Gateway Questions and Answers document has been updated and can be found here
12-03-2012
Electronic Application Forms for initial Marketing Authorisation Applications (Human), Variations (Human and Veterinary) and Renewals (Human and Veterinary) v1.0.0 are available and can be viewed 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
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