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

20/10/2011 (e)Submission content plan and document templates
eCTDconsultancy has, together with sister company Qdossier, developed ....

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 ....

03/05/2010 - New eSumission guideline FAGG
Fagg has published the new eSubmission guideline on their website. The guidance ....

05/02/2010 - ASMF final draft guidance document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

05/02/2010 - New Belgian checker v2.8 released
FAGG has released a new version of the Belgian eSubmission checker. Since ....

23/11/2009 - HMA: All NCA's ready to accept electronic only
The HMA (Heads of Medicines Agencies) published a special press ....

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

11/09/09 - EU NEES validation criteria v1.0
A set of technical validation criteria to be applied to all non-eCTD electronic ....

24/07/09 - EU M1 version 1.4
The EU M1 will be updated to support the new Variation Regulation coming into ....

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 ....

06/01/09 - eCTD for Regulatory Affairs and beyond
This course will offer insight into the regulatory environment for human ....