News archive
2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada
  The Common Electronic Submissions Gateway (CESG) is a method of ....

26/02/2014 TGA reaches Electronic-only (eCTD) submissions milestone
The TGA has signed an agreement to use the docuBridge software solution to ....

REMINDER: EMA gateway made mandatory
As of the 1st of March 2014, the use of the eSubmission Gateway or web client ....

14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures
The FDA Guidance Agenda can be found here:New & Revised Draft Guidances CDER ....

14/02/2014 EMA introduces product numbers to track medicines through pre-authorisation procedures
The European Medicines Agency has introduced unique product identifiers ....

20/12/2013 European Medicines Agency and FDA announce launch of generic medicines application inspections initiative
The European Medicines Agency (EMA) and the United States Food and Drug ....

03/12/2013 European Medicines Agency closed 23 December 2013 to 2 January 2014
The European Medicines Agency will be closed from 18:30 on Friday 20 December ....

29/11/2013 European Medicines Agency and EUnetHTA agree joint work plan
The European Medicines Agency (EMA) and EUnetHTA, the European Network for ....

11/11/2013 Updated information on PSUR submissions in Single Assessment via EMA Gateway Webclient
There has been an update on the information regarding the PSUR submissions in ....

14/10/2013 EMA encourages companies to submit quality type I variations for 2013 by end of November
The European Medicines Agency is advising marketing authorisation holders to ....

11/10/2013 EMA launches a new version of EudraCT
The European Medicines Agency has launched version 9 of the European Clincial ....

08/10/2013 EMA introduces digital signatures for selected procedures
The European Medicines Agency has revised the rules on fees payable to the ....

08/10/2013 EMA Revised dossier-submission requirements for active-substance master files
The European Medicines Agency has updated its pre-authorisation procedural ....

13/09/2013 EMA ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs)
The Implementation Guideline can be found here: EMA ICH guideline E2B (R3) ....

13/09/2013 EMA Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure
This question and answer (Q&A) document provides practical considerations ....

09/08/2013 EMA update on formatted table template in Cover Letter
The EMA has updated the formatted table template. When companies submit ....

29/07/2013 EMA Updated variations application form for human and veterinary medicines
The EMA has published new updated versions of the electronic variation ....

04/07/2013 Practical guidance on the extension of Commission Decision Annexes in the new Accession Country language
  This Guidance document provides details on the inclusion of the new ....

04/07/2013 Guidance on centrally authorised products requiring a notification of a change for update of annexes
On 23 July 2010 and after a consultation phase, the EMA communicated to all ....

04/07/2013 dates of 2014 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel EMA/HTA request
The following document provides the dates of 2014 SAWP meetings and deadlines ....

04/07/2013 European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
This guidance document addresses a number of questions which marketing ....

04/07/2013 Member states contact points for translations review
The following document provides the European Medicines Agency member states ....

04/07/2013 EMA pre-authorisation procedural advice for users of the centralised procedure
  This guidance document addresses a number of questions which users of ....

04/07/2013 EMA Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products
This paper describes the publication of information on the withdrawals of ....

04/07/2013 EMA Publication and access to clinical-trial data
There is growing demand from external stakeholders for full transparency, not ....

04/07/2013 EMA concept reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
The reflection paper (RP) should provide an overview of statistical ....

24/06/2013 EMA releases for public consultation its draft policy on the publication and access to clinical-trial data
The European Medicines Agency has released a draft policy on the publication ....

21/06/2013 EMA Revised Implementation Guide for EU Module 1 eCTD/NeeS validation criteria
On 1 March 2013 the EMA published a new version of the EU eCTD M1 ....

20/06/2013 Guidance on centrally authorised products requiring a notification of a change for update of annexes
On 23 July 2010 and after a consultation phase, the EMA communicated to all ....

20/06/2013 Guideline on the use of bovine serum in the manufacture of human biological medicinal products
This guideline outlines the general principles that should be applied to the ....

19/06/2013 Final guideline on active substance master file procedure
The main objective of the Active Substance Master File (ASMF) procedure, ....

31/05/2013 Revised version of application form medicinal products for human use
Notice, the administrative information application form, Volume 2B, module ....

30/05/2013 NCA and EMA requirements for submission of PSUR
This document aims at making publicly available the submission requirements ....

UPDATE : 16/05/2013 Adoption of guidelines on the details of various categories of variation
The Commission has adopted the Guidelines on the details of the various ....

27/05/2013 Agreement between Israel and the EU on conformity assessment and acceptance of industrial products; Q&A
The agreement between Israel and the EU on conformity assessment and the ....

24/05/2013 EMA Member states contact points for translation review
The latest EMA Member states contact points for translation review ....

28/05/2013 EMA Formatted table template update for procedural submission cover letter
The formatted table template, included in each in each procedural submission ....

24/05/2013 EMA pre-authorisation procedural advice centralised procedure
This guidance document addresses a number of questions which users of the ....

24/05/2013 EMA post-authorisation procedural advice centralised procedure
This guidance document addresses a number of questions which MAHs may have on ....

16/05/2013 Adoption of guidelines on the details of various categories of variation
The Commission has adopted the Guidelines on the details of the various ....

16/05/2013 EMA Annual report to the European Commission on benefits and infringements under the Paediatric regulation
  Report to the European Commission on companies and products that have ....

02/05/2013 EMA Deadlines for submission orphan medicinal product designation
Deadlines for submission of applications for orphan medicinal product ....

10/04/2013 EMA Guidance on format of the risk management plan in EU part VI: Summary
The EMA Guidance on format of the risk management plan (RMP) in the ....

10/04/2013 EMA Guidance on format of the risk management plan in EU for Generics
The EMA Guidance on format of the risk management plan (RMP) in the EU for ....

10/04/2013 EMA Guidance on format of the risk management plan in the EU
The EMA Guidance on format of the risk management plan (RMP) in the EU - ....

25/03/2013 EMA Guideline on the declaration of quantitative compostion/labelling of biological medicinal products
This guideline outlines the approaches to be followed for declaring the ....

22/03/2013 EMA revision of labelling and leaflet checking process
Since February 2007 the EMA has been operating an extensive checking process ....

19/03/2013 EMA practical guidance on the extension of Commision Decision Annexes
This Guidance outlines practical considerations concerning the phasing-in of ....

15/03/2013 EMA Reporting requirement of individual case safety reports applicable to MAHs
The EMA Reporting requirements of Individual Case Safety Reports (ICSRs) ....

15/03/2013 Form MAH when submitting translation to the national competent authority of Croatia
EMA Form 1 for marketing authorisation holders when submitting ....

12/03/2013 EMA Guideline on use of CTD format in preperation of a registration
This document aims to provide guidance on how to present the application for ....

11/03/2013 EMA Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications
Seasonal influenza vaccines for human use authorised via the centralised ....

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 ....

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