Launching a pilot for fast-track approval of clinical trials in the EU/EEA

The goal is to – from January 2026 – provide the pharmaceutical industry with greater predictability in assessment and approval times for clinical trials, strengthen trust in European regulatory authorities, and facilitate increased research investments in Europe. This is while maintaining scientific, safety, and ethical standards, writes the Heads of Medicines Agencies (HMA).

Important to keep up in the global competition for trials

The fast-track scheme in Europe, which is a pilot, has been named FAST-EU (Facilitating and Accelerating Strategic Trials), and is part of the EU's overarching effort to strengthen clinical research in Europe. The initiative aligns with the European Commission's upcoming legislative proposal to simplify procedures for multinational clinical trials in the EU.

The European Medicines Agency (EMA) supports the initiative.

- This is a significant step forward, fully in line with the common goal of making Europe a more attractive place for clinical research and improving patients' timely access to innovative medicines. FAST-EU will be reflected in the upcoming work plan for Accelerating Clinical Trials in the EU (ACT EU), and EMA will support this work with technical expertise and by facilitating processes through the Clinical Trials Information System (CTIS), writes EMA on LinkedIn.

The initiative is an attempt to coordinate European countries, as Europe continues to lose ground to the USA and Asia, and some individual countries have launched their own promises for fast approvals of clinical trials.

Individual countries have taken the lead

Danish authorities have significantly reduced the approval time for mononational clinical phase 1 and 2 trials to 14 days since August 14 this year. This is the fastest in Europe.

- This step solidifies Denmark's role as a leader in life sciences and attracts more global pharmaceutical and biotechnology companies to test and launch treatments here first, writes the Danish Ministry of Foreign Affairs.

Also, Swedish authorities have cut the approval time to 30 days for mononational studies since September 1 this year.

- The idea behind the fast track is to strengthen Sweden's position as an attractive country for research in the Life Science sector, writes the Swedish Medical Products Agency.

Norway joins the pilot

- Norway prioritizes joining the common European pilot, says Ingvil Sæterdal, head of Clinical Trials and Innovation at the Norwegian Medicines Agency, DMP.

According to HMA, FAST EU will also have clear and ambitious timelines and include mechanisms for better coordination. However, the details are not yet known.

- Meetings and negotiations are currently ongoing, and we expect the authorities to reach an agreement on a framework that will apply from January. Then we will also receive more information on how sponsors can apply to include trials in the pilot, says Sæterdal.

- Important that DMP and REK KULMU are joining

- Simple and fast approval processes are very important for the pharmaceutical industry, says Ina Dahlsveen, senior advisor at LMI.

- Norway is rarely among the countries chosen first when companies decide where to conduct clinical studies. Therefore, it is important - and good - that DMP and REK KULMU are offensive and make it possible for Norway to be part of the train that is now leaving. We understand that DMP wants to contribute to HMA and EMA's ambitions to improve the system across Europe, but we must also remember that Norway is competing against other countries for studies, says Dahlsveen.

NorTrials is also positive about DMP joining the FAST-EU pilot.

- For NorTrials, it is important to highlight all the advantages of choosing Norway as an attractive country – not only in the healthcare sector but also on the authority side. Therefore, it is very positive that DMP is part of this European initiative, says the head of NorTrials coordinating unit, Signe Øien Fretland.