On January 13, 2022, the EU launched an initiative, ACT EU, that aims to transform and accelerate how clinical trials are initiated, designed, and conducted. The initiative is led by the European Commission (Commission), the Heads of Medicines Agencies (HMA), which is a network of all of the EU Member States’ medicines agencies, and the European Medicines Agency (EMA).
ACT EU comes just a few days before the new EU Clinical Trials Regulation (Regulation 536/2014) will become applicable on January 31, 2022. This new regulation will significantly change how clinical trial sponsors will apply for, conduct, report, and advise outcomes and results for clinical trials in the EU. Continue reading