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FAST-EU: Facilitating and Accelerating Strategic Clinical Trials in the EU/EEA

19/02/2026 Regulatory news

Clinical trial sponsors can express an interest in taking part in FAST-EU (Facilitating and Accelerating Strategic Clinical Trials). FAST-EU is a pilot initiative  aiming to accelerate the assessment and authorisation of clinical trials running in multiple EU/EEA countries.

Under FAST-EU, the full process for an application – from submission in CTIS to final decision – will take a maximum of 10 weeks (70 days), including sponsor response times.

The pilot is currently open for submissions and is expected to run until early 2027.

For further details, including how to take part, visit our FAST-EU webpage.