EMA welcomes publication of new clinical trials regulation

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.