FAST-EU pilot initiative
The EU Heads of Medicines Agencies, the Clinical Trial Coordination Group and MedEthics EU have launched the FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) pilot initiative. The objective of this initiative is an accelerated and coordinated assessment and authorisation of multinational clinical trial applications. It aims to reduce the overall duration from submission to legal Clinical Trial Regulation decision(s) to 70 calendar days while maintaining scientific, safety and ethical standards.
FAST-EU, aims to improve the predictability and efficiency of assessment timelines, strengthen coordination between Member States, support the EU's capacity for rapid and coherent regulatory action, and facilitate timely access to innovative therapies for patients.
A voluntary pilot, FAST-EU will evaluate letters of intention for the pilot with a response on participation within 5 working days. It will apply to initial applications for multinational clinical trials with several participating Member States and all categories of investigational medicinal products. Among the key criteria for participation is the readiness of the dossier for submission.
FAST-EU fully integrates the Ethics Committee opinion of all participating Member States concerned and will accelerate the assessment process through the implementation of parallel workflows.
