The European FAST-EU initiative, which aims to accelerate the assessment of multinational clinical trials, will extend its scope from November 2026 to include requests for substantial modifications required to comply with conditions set out in clinical trial authorisations.
This extension allows sponsors to benefit from accelerated assessment procedures at this stage of the regulatory process, helping to reduce the time required to initiate clinical trials and strengthening the attractiveness of the European Union and European Economic Area (EU/EEA) as destinations for clinical research. The measure streamlines regulatory procedures, bringing forward the start of clinical trials and patients’ access to new therapeutic options, while safeguarding participant safety and rights, as well as data quality.
Launched on 30 January 2026, FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) is an initiative promoted by the Heads of Medicines Agencies (HMA), the Clinical Trials Coordination Group (CTCG) and MedEthicsEU. It operates within the framework of the European Clinical Trials Regulation through the Clinical Trials Information System (CTIS).
Portugal’s role in FAST-EU
Since the initiative’s launch, 38 clinical trials have been selected for accelerated assessment across the EU/EEA, 13 of which involve Portugal. In two of these trials, Portugal serves as the Reporting Member State, while in the remaining 11 it participates as a Member State Concern.
Portugal’s participation accounts for approximately one-third of all clinical trials selected under the initiative. This highlights the country’s involvement in European efforts to streamline regulatory procedures and its contribution to making Europe a more competitive and attractive destination for clinical research.
The latest expansion marks a new stage in the FAST-EU initiative, extending accelerated assessment to substantial modifications submitted in response to conditions set out in the initial authorisations of the clinical trials covered by the initiative.
