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European Pilot Initiative: A Fast-Track Approach To Processing of Clinical Trial Applications

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Norway is participating in a European pilot initiative aimed to accelerate the assessment of multinational clinical trials. The initiativ is expected to start in January 2026.

The pilot, called “FAST-EU (Facilitating and Accelerating Strategic Trials)”, is part of the European Commission's efforts to boost the number of clinical trials conducted across Europe. Both the Norwegian Medicines Agency (NOMA) and the Regional Committees for Medical and Health Research Ethics (REK KULMU) are involved in this initiative.

Work is currently underway to finalise details about the practical aspects of the application process, as well as the criteria for selecting studies suitable for inclusion in the pilot. We will provide updates on our website as more information becomes available.

For more information about this initiative, please refer to the press release from the Heads of Medicines Agencies (HMA)

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