Portugal authorises its first clinical trial under the European FAST-EU pilot project
30 jul 2026
Portugal authorised its first clinical trial today as the Reporting Member State under the European pilot project Facilitating and Accelerating Strategic Clinical Trials in the EU/EEA (FAST-EU), meeting the new reduced timeline of 70 days and further strengthening its role in the implementation of this European initiative.
FAST-EU is a joint initiative of the Heads of Medicines Agencies (HMA), the Clinical Trials Coordination Group (CTCG) and MedEthics EU, developed within the framework of Accelerating Clinical Trials in the European Union (ACT EU). The pilot project is testing a new assessment model designed to accelerate the authorisation of multinational clinical trials across the European Union.
Portugal is participating in 8 of the 23 clinical trials selected for submission through this European mechanism, highlighting INFARMED's strong involvement in the implementation of the pilot project. To date, five clinical trials have already been authorised, while the remaining three are currently under assessment and are expected to meet the new 70-day timeline, representing a significant reduction compared with the current regulatory timeframe of 106 days.
The FAST-EU pilot project anticipates some of the changes envisaged to the European Clinical Trials Regulation under the forthcoming European Biotech Act. The project aims to demonstrate that regulatory assessment procedures can be accelerated while maintaining the high standards of quality, safety and scientific rigour required for the authorisation of clinical trials.
By actively participating in this initiative, Portugal is contributing to the development of a more agile and harmonised regulatory system, strengthening Europe's attractiveness as a location for multinational clinical trials and promoting faster access for citizens to therapeutic innovation.
