News Archive

New draft version of EU eCTD Module 1 v3.0 released for public consultation

22.07.2015
Flag of EU

A new draft revision of the future version 3.0 for the EU eCTD Module 1 has been released on the CMB eSubmission website. The release consists of the following documents:

Release...[more]

EMA releases revision 18 of the Dossier requirements for Centrally Authorised Products

15.05.2015
Flag of EU

The European Medicines Agency (EMA) has released a new revision 18 of the "Dossier requirements for Centrally Authorised Products (CAPs)".

Revision 18, dated 08 May...[more]

EMA releases further updates to Procedural Advices for Users of the Centralized Procedure

05.05.2015
Flag of EU

The European Medicines Agency has recently been very busy in producing updates to their "procedural advice for users of the centralised procedure". In April two updates,...[more]

CMDh releases updated submission requirements for MRP/DCP and national procedures

30.04.2015
FLag of EU

The CMDh has released updated submission requirements (number and format) for applications within MRP, DCP and national procedures. The update concerns new applications and...[more]

National implementation of EU eSubmission roadmap - information from German BfArM and PEI

27.04.2015

In line with the EU eSubmission roadmap that was adopted in November 2014, the German drug regulatory agencies BfArM and Paul Ehrlich Institute (PEI) have released corresponding...[more]

National implementation of EU eSubmission roadmap - information from UK MHRA and CZ SUKL

15.04.2015

The EU eSubmission roadmap has already been adopted in November 2014 (see link here). One major objective of the eSubmission roadmap is to switch from paper to electronic format...[more]

EMA releases revision 48 of the Post-Authorisation Procedural Advice for Users of the CP

14.04.2015
Flag of EU

A new revision 48 of the "Post-authorisation procedural advice for users of the centralised procedure" has been released by EMA this week.

The new revision now includes...[more]

Displaying results 1 to 7 out of 196

1

2

3

4

5

6

7

Next >

© 2007 - 2017 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com