02/02/2012 Start collecting your XEVMPD data today to meet the aggressive timelines..
To populate and update the EVMPD, all Marketing Authorisation Holders have to ....

20/10/2011 (e)Submission content plan and document templates
Qdossier introduces a full set of (e)Submission document templates that ....

11/05/2011 Update of BfArM eValidator
A new version of the "eValidator" used by German BfArM has been released. The ....

18/04/2011 RAPS "Advanced eCTD submissions" - Longbeach CA, 20 - 22 July 2011
Hans van Bruggen will present on "eSubmissions in the EU" ....

01/12/2010 EMA widens public access to documents
The European Medicines Agency (EMA) has published its new policy on access to ....

29/11/2010 EMA released draft guideline on biosimilar medicines
EMA has released the draft guideline on similar biological medicinal ....

01/12/10 - 03/12/10 - DIA Conference on European Electronic Document Management
In an evolutionary environment, it seems that every time one overcomes a ....

08/11/2010 PIM Guidance for Applicants V3.1
PIM Guidance for Applicants V3.1 is available for download here. For details ....

05/11/2010 CMD(h) updates requirements on eSubmissions for New Applications within MRP, DCP or National Procedures
An updated document with national requirements on electronic submissions for ....

05/02/2010 - ASMF final draft guidance document
A joint working group comprising representatives from EU Regulatory ....

04/02/2010 - New Belgian checker v2.8 released
FAGG has released a new version of the Belgian eSubmission checker. Since ....

21/09/2009 - New Electronic Application Forms NTA Vol 2b
The Notice to Applicants Volume 2b on the Eudralex website has ....

16/07/09 - Swiss eCTD Module 1 specifications and validation criteria
Swiss Medic has published drafts of the 'Swiss eCTD Validation Criteria' ....

01/07/09 - EMEA updated dossier requirements for post-authorisation submissions
The EMEA has updated the new Dossier requirements for Post-authorisation ....

15/05/09 - CMD(h) requirements on electronic submissions
The CMD(h) have published their requirements on electronic submissions for New ....

15/05/09 - Revised v2.1 EU eCTD validation criteria
A revised v2.1 of the EU eCTD validation criteria has been published by ....

30/03/09 - Swiss Medic to accept eCTD in 2010
Swiss Medic has announced on their website to accept eCTD in 2010. Recenlty a ....

26/03/09 - CMD(h) eCTD Implementation Report available
The CMD(h) has published the eCTD Implementation Report covering the period ....

27/01/09 - EMEA dossier requirements for Post-authorisation submissions
The EMEA has adopted the new Dossier requirements for Post-authorisation ....

20/01/09 - TGA eCTD draft guidance v1.5
The TGA has initiated a project that will culminate with the data dossiers for ....

13/01/09 - EMEA eCTD implementation strategy
EMEA has announced plans to mandate the use of the Electronic Common Technical ....