RegulatoryOfficial

FAST-EU accelerated review extended to substantial modifications for conditions of trial authorisation

🇵🇹 INFARMED · Thu 05 Nov 2026

From November 2026, FAST-EU covers substantial modification requests needed to meet conditions set in clinical trial authorisations, INFARMED reports, with Portugal in 13 of 38 selected trials.

The European FAST-EU initiative, designed to speed up assessment of multinational clinical trials, now also covers substantial modification applications, INFARMED announced on 5 November 2026. The extension applies from November 2026 to requests needed to satisfy conditions attached to the authorisation of a trial.

The Portuguese authority said sponsors can now use accelerated assessment procedures at this stage of the regulatory process as well. It argues this should shorten the time taken to start trials and make the EU and European Economic Area more attractive for clinical research, while protecting participant safety, rights and data quality.

FAST-EU (Facilitating and Accelerating Strategic Clinical Trials) was launched on 30 January 2026. It is run by the Heads of Medicines Agencies (HMA), the Clinical Trials Coordination Group (CTCG) and MedEthicsEU under the EU Clinical Trials Regulation, using the Clinical Trials Information System (CTIS).

Since launch, 38 trials have been selected for accelerated assessment across the EU/EEA, 13 of which involve Portugal. INFARMED says Portugal is reporting Member State in two of them and Member State concerned in the other 11, roughly a third of the selected trials.

The notice does not set out eligibility criteria, submission mechanics or specific timelines for the accelerated modification route. It describes the change only as covering substantial modifications submitted in response to conditions in the initial authorisation of trials within the initiative.

What it means for your team

  • Sponsors with trials in FAST-EU that carry authorisation conditions may be able to use accelerated assessment for the related substantial modifications.
  • The extension is limited to modifications responding to authorisation conditions, not substantial modifications generally, according to the notice.
  • Teams should look for guidance from HMA, CTCG or national agencies on eligibility, procedure and timelines, as INFARMED's notice does not give them.
  • Portugal's role as reporting or concerned Member State in 13 selected trials suggests it is an active participant in the pathway.

Official source: INFARMED ↗

Article written by VigiEye from the official source (INFARMED). AI-assisted; check the source before acting.

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