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  1. / English / News / EMA revises guidelines for first-in-human studies

    News

    To facilitate matters for actors and reduce the risks for participants in clinical studies, the European Medicines Agency (EMA) has revised its guidelines for first-in-human studies.

    Last modified: 2017-11-24
  2. / English / News / New EU-wide law for clinical studies delayed until 2019

    News

    EMA reports that the point in time when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into force has been delayed from October 2018 to 2019. The decision was

    Last modified: 2017-11-24
  3. / English / News / New legislation for medical devices

    News

    On Friday 26 May, two new medical technology directives come into force. The new legislation has been negotiated within the EU. The purpose of the directives adopted – one for medical devices and one for

    Last modified: 2017-11-27
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