The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, is expected to begin testing a new accelerated European approach to the evaluation and authorisation of selected multinational clinical trials at the end of January 2026. In addition to the Paul-Ehrlich-Institut, numerous sister authorities in the European Economic Area (EEA) and their respective ethics committees have committed themselves to testing the new accelerated FAST-EU approach under the leadership of the Heads of Medicines Agencies (HMA) network. This should significantly reduce the processing times for clinical trial authorisation applications, strengthen cooperation between EEA Member States, and make innovative treatments available to patients sooner.
Source: raker/Shutterstock
FAST-EU stands for "Facilitating and Accelerating Strategic Trials in the EU". The aim of the programme is to make clinical trial authorisation procedures in the EU and the EEA easier and quicker. This is a coordinated fast-track procedure for the evaluation and authorisation of multinational clinical trials. The pilot project is an important part of the overall drive to strengthen clinical research in Europe and is in line with the European Commission's upcoming legislative initiative to simplify and streamline procedures for multinational clinical trials.
The FAST-EU approach foresees clear deadlines and reliable coordination mechanisms. The aim is to provide sponsors of clinical trials with greater transparency in evaluation and authorisation timelines, to strengthen sponsors' confidence in the European regulatory system, and to increase the attractiveness of research investments. The high scientific, safety, and ethical standards will be maintained.
The FAST-EU project is intended to demonstrate the EU's ability to coordinate and respond rapidly, to reinforce Europe's global competitiveness in biomedical research, and to ensure that patients in Europe benefit sooner from scientific advances and therapeutic innovations. It also sends a clear signal for innovation and cooperation within and between EEA Member States. In contrast to other regions of the world, the opinions of the ethics committees of all participating Member States are already integrated into the FAST-EU procedure.
Together with the other participating Member States, the Paul-Ehrlich-Institut is currently developing more detailed information on the FAST-EU pilot project, such as specific deadlines and process operations.
Multinational clinical trials account for a significant proportion of authorised studies in Europe. They are essential to include a sufficient number of patients from different countries, to achieve robust results, and to accelerate the development of innovative therapies. Promoting clinical trials in Europe also ensures that European patients are involved in the development of these therapies and can thus benefit from scientific advances at an early stage.
Updated: 12.12.2025
