Three months after the launch of the European pilot project FAST-EU, significant progress is already evident: 15 multinational clinical trials are currently underway under the fast-track procedure, three of which were completed within the 70-day target. “This new FAST-EU procedure marks a milestone for clinical research in Europe and is intended to significantly speed up the approval of multinational clinical trials within the EU/EEA area,” emphasises Günter Waxenecker, Head of the AGES Medical Market Surveillance Division, on today’s “Clinical Research Day”. A broad European consensus was required to make this initiative a reality. After all, a strong and supportive environment for clinical trials is crucial to ensuring that tested medicines continue to reach patients quickly and remain available in the future. “We are therefore proud that AGES was able to make an important contribution as a source of ideas and impetus in the design and introduction of the accelerated procedure for the authorisation of multinational clinical trials,” says Waxenecker.
Pilot demonstrates Europe’s capacity for accelerated and coordinated authorisation of clinical trials
As early as 26 November 2025, numerous heads of European regulatory authorities, representatives of the European Medicines Agency (EMA), the European Commission, heads of clinical trials departments and ethics committee representatives gathered at AGES in Vienna and agreed to test a coordinated “fast-track” approach for a swifter and more efficient assessment of multinational clinical trials. The approach bears the forward-looking name FAST-EU (Facilitating and Accelerating Strategic Trials in the EU/EEA) and launched at the start of 2026. The procedure provides for clear and ambitious timelines, coordination mechanisms and parallelised processes, whilst fully maintaining scientific, safety and ethical standards. The opinions of the ethics committees of all participating Member States are already integrated into this ambitious process. As part of the project, this originally Austrian idea – conceived under the leadership of AGES experts Marianne Lunzer and Stefan Strasser and elevated to the European level – is now being put into practice.
Initial interim results promising, high demand from sponsors
The Clinical Trials Coordination Group (CTCG) under the umbrella of the Heads of Medicines Agencies (HMA) and MedEthics EU under the auspices of the European Commission are publishing the first interim results. The pilot project, launched in early 2026, serves as a test run for simplified and coordinated authorisation procedures as part of the revision of the EU Clinical Trials Regulation in the context of the Biotech Act. This new procedure aims to enable a shorter, simpler and more predictable authorisation process – whilst maintaining the highest standards in terms of participant safety and data quality. In the first three months, the FAST-EU Coordination Office received 68 expressions of interest from sponsors in Europe and worldwide. Of these, 15 procedures were included in the pilot project – three in February, four in March, four in April and four in May 2026.
First completed procedures confirm the feasibility of the 70-day target
The number of applications exceeded the originally planned capacity of two procedures per month, reflecting both the high level of interest from sponsors and the willingness of Member States to meet the increased demand. The 15 selected studies cover a broad spectrum of therapeutic areas, including oncology and haematology (7 studies), neurology and neurodegenerative diseases (2), cardiovascular and pulmonary vascular diseases (2), and immunology and inflammatory diseases (2). The studies span all development phases (Phase I to III) and involve an average of 7.33 participating Member States per procedure, with up to 14 Member States in individual studies. To date, three procedures have been completed, all of which have met or come close to meeting the target of 70 calendar days. These results demonstrate that the 70-day timeframe is operationally feasible for different study types, indications and constellations of Member States.
Strong participation by Member States and significance for the EU Biotech Act
A total of 26 EU Member States and EEA countries are participating in the FAST-EU project. The distribution of Reporting Member States (RMS) underscores the pan-European nature of the initiative. A comprehensive final report will be published upon completion of the pilot project. Sponsors wishing to submit an expression of interest may contact the FAST-EU Coordination Office at FAST-EU@hma.eu. Further information is available in the “FAST-EU External Guidance for Sponsors” on the CTCG website.