EMA welcomes publication of new clinical trials regulation

Published: 16-Jun-2014
Regulatory

Regulator to prepare IT systems to help authorisation and supervision of clinical trials


The European Medicines Agency (EMA) has welcomed the publication of the European Union’s new clinical trials regulation in the EU Official Journal.

While authorisation and oversight remains an EU member state responsibility, the new legislation mandates EMA to prepare IT systems to help sponsors and experts authorise and supervise clinical trials, ensuring safety reporting and enhanced information access.

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  • EMA European Medicines Agency
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