FAST-EU project accelerates the assessment of multinational clinical trials in Europe

National medicines authorities and ethics committees in Europe are starting to pilot the accelerated assessment model for the assessment of multinational clinical trials. Finland is involved in piloting the new model as well.

The FAST-EU (Facilitating and Accelerating Strategic Trials) project is part of the EU’s objective of having more clinical trials in Europe. Starting in January 2026, the project will support the European Commission’s upcoming legislative initiative aimed at simplifying the procedures for multinational clinical trials in the EU.

The objective of FAST-EU is to clarify the timetables for assessment and authorisation processes, improve coordination between authorities and ethics committees, increase predictability for the parties commissioning trials, and strengthen trust in the European regulatory system. Another objective is to attract research investments and strengthen Europe’s global competitiveness and ensure that European patients benefit from scientific advances and innovations. 

Multinational clinical trials account for a significant proportion of trials approved in Europe. This enables recruiting a sufficient number of patients from different countries for achieving reliable results and speeding up the development of innovative treatments. 

Further information will be published subsequently on the website of the European Medicines Agency’s network HMA.

More information: hma.eu