News Archive

South Africa MCC updates eCTD implementation roadmap

27.10.2014
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The Medicines Control Council (MCC) of South Africa has updated their roadmap for the implementation of the eCTD. Since June last year an eCTD pilot phase is running at the MCC...[more]

Australian TGA updates eCTD FAQ

24.10.2014
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The Australian Therapeutics Good Administration has updated their "Australian eCTD submissions: Frequently asked questions" website (see also link at the bottom of this...[more]

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]

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