The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a larger workplan to accelerate the adoption of clinical trials in the EU. The priorities are meant to steer the agencies’ work from 2022-2026.
The workplan was adopted under the auspices of the EC-HMA-EMA initiative Accelerating Clinical Trials in the EU (ACT EU), which launched earlier this year. (RELATED: EU launches clinical trials transformation initiative, Regulatory Focus 18 January 2022)
ACT EU aims to transform how clinical trials are initiated and run and to promote clinical research in the EU.
The workplan “builds on the entry into application of the Clinical Trials Regulation (Regulation (EU) No 536/2014) and the activities already underway in the European regulatory network to support clinical trials. The workplan highlights key focus areas to further facilitate innovation in clinical trials, stakeholder engagement and regulatory network collaboration.”
It lays out deliverables that include mapping and governance, good clinical practice (GCP) modernization, enhanced clinical trial data analytics and clinical trial safety reforms…
