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EC submissions


News on submissions in EU

Which changes are planned for EC sub­missions in EU for 2016 one can read on ec.europa.eu page. This New Clinical trials Regulation (from 16 April 2016) was planned to come into force in Germany in July 2016 or later in the EU. This has now been delayed considerably in all EU countries. So far only few info meetings are offered on this new Regulation, since practical aspects are still in development.

Here you find the EU regulation 536/2014 in English - New Clinical Trials Regulation EU 536/2014.

The revision 14.1 of the Guideline on the packaging information of medicinal products for human use authorised by the Union from March 2015 is published - PDF 2012.07 Proposal

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance (Text only german) - Regulation (EU) No 536/2014 PDF

Pilot Project for Germany with approval within ca 30 days

Pilotprojekt wurde am 1.10.2015 gestartet. Der erste Genehmigungsantrag im Rahmen des Pilotprojekts wurde am 4.12.2015 bei der zuständigen Ethik-Kommission und der zuständigen Bundesoberbehörde eingereicht und fristgerecht am 8.01.2016 beendet. Interessierte Sponsoren können ab jetzt mit einem „letter of intent“ die Teilnahme ihrer Verfahren am Pilotprojekt beantragen.

In Dec15 a pilot project started in Germany which would mean for a client who wants to submit in Germany a multicenter clinical study via the German NCA (BfArM or PEI) it might take only ca.

30 days from submission to approval for a multicentric drug trial from NCA and CEC. The first projects were done and it took only ca. 35 days. This all at no extra costs. Find out more details via the link under this text or give us a call.

Details unter: http://www.bfarm.de/DE/Arzneimittel/zul/klinPr/pilotprojekt/_node.html

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