"A strong and supportive environment for clinical trials is crucial to ensure that safe and effective medicines reach patients quickly and remain available in the future. We are proud that Austria was able to make an important contribution to European cooperation as a provider of ideas and impetus in the conception and introduction of an accelerated procedure for the approval of multinational clinical trials," emphasises Günter Waxenecker, Head of Business Unit at AGES Medical Market Inspectorate, who hosted a groundbreaking international kick-off meeting in Vienna together with the Chairwoman of the Heads of Medicines Agencies (HMA) María Jesús Lamas Díaz (AEMPS, Spain). The aim of the meeting was to agree on an accelerated procedure for the approval of multinational clinical trials in the European Union, to define the approval criteria and to prioritise the next steps for the implementation of FAST-EU (Facilitating and Accelerating Strategic Trials in EU/EEA).
Milestone for clinical research in Europe
On 26 November 2025, numerous European heads of authorities, heads and staff of clinical trial departments and representatives of ethics committees agreed to test a faster assessment of multinational clinical trials through an improved process flow. The European Medicines Agency (EMA) and the European Commission were represented at a high level at this meeting and support the initiative for a fast track system. "This new procedure marks a milestone for clinical research in Europe and should significantly speed up the approval of multinational clinical trials in the EU/EEA. A broad European agreement was necessary to make this initiative a reality," emphasised Marianne Lunzer, Chair of the Clinical Trials Coordination Group (CTCG), and Stefan Strasser, Head of the Clinical Trials Department at AGES Medical Market Inspectorate, on the occasion of the agreement.
FAST-EU: launch in January 2026
FAST-EU is part of the comprehensive European strategy to strengthen competitiveness in biomedical research. The procedure provides for clear and ambitious timelines and coordination mechanisms to offer sponsors of clinical trials clearer and shorter assessment and approval periods. In contrast to other regions, the opinions of the ethics committees of all participating member states are already integrated into this ambitious process. The aim is to provide the highest ethical and scientific standards for the clinical profiling of innovative product candidates in Europe. In doing so, the EU is sending out a clear signal in favour of pharmaceutical innovation and increased cooperation between the member states.
More benefits for patients and researchers
Multinational clinical trials account for a significant proportion of authorised trials in Europe. They are essential to include enough patients from different countries, achieve robust results and accelerate the development of innovative therapies. Funding such studies in Europe ensures that European patients benefit from scientific advances at an early stage. FAST-EU will start in January 2026 and aims to significantly increase Europe's attractiveness for clinical research. This will ensure that patients in Austria and the EU have earlier and continued safe access to innovative therapies.