News Archive

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

15.05.2015
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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
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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]

FDA revises example submission code using the new Module 1 version 2.3

21.04.2015
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The FDA has released some some revised information related to the forthcoming new Module 1 version 2.3 which is targeted to come into effect in Q3 2015. The revision concerns the...[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]

Australian TGA releases final eCTD specification, revises NeeS format

14.04.2015
Flag of Australia

The Australian Therapeutic Goods Administration (TGA) has released the first final specification for the Australian eCTD.

Since late 2014 the TGA was accepting eCTD submissions...[more]

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