News Archive

EMA updates Dossier requirements

13.10.2014
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EMA has released some updates to their "Dossier requirements for Centrally Authorised Products". The new updates released in October address the fact that Hungary and...[more]

EMA updates Pre-Authorisation Procedural Advice for CP users

09.10.2014
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EMA has released another update of the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" (EMA/339324/2007).

The new...[more]

FDA releases PDF specification 4.0

07.10.2014
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The U.S. Food and Drug Administration (FDA) has released a new version 4.0 of their "Portable Document Specifications (PDF)". The PDF specification itself is referenced...[more]

Update! - Electronic application forms updated

02.10.2014
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!Update from 02 October 2014!

Meanwhile a new minor version (Release note version 1.16.0.1) has been released for all that addresses a critical issue in version 1.16.0.0 that...[more]

EU Telematics Management Board releases new strategy paper 2014 - 2016

01.10.2014
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The EU Telematics Management Board has released a new strategy paper: "EU Telematics Strategy 2014 - 2016".  New governance structures were put in place in 2013 to...[more]

EDQM releases updated application forms to be used from 01 October

26.09.2014
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The European Directorate for the Quality of Medicines & Healthcare (EDQM) has released updated versions of the application form required for requests for certificates of...[more]

EU CMDh updates overview table of submission requirements for PSURs

26.09.2014
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A new revision 1, dated September 2014 of the "Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products...[more]

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