12/02/2025  |  Nicole Verbeeck  |  Euractiv Health Across Europe

https://www.euractiv.com/news/belgium-joins-fast-eu-pilot-accelerating-multinational-clinical-trials/ 

Belgium is reducing mononational clinical trial approval timelines by 27 days per application

Belgium has confirmed it will take an active role in FAST-EU, Europe’s new coordinated fast-track mechanism for multinational clinical trials. Participation will position Belgium as an operational test case for the bloc’s drive to modernise clinical trial authorisation.

FAST-EU (Facilitating and Accelerating Strategic Trials) aims to speed up and harmonise the authorisation of multinational clinical trials across the EU/EEA by introducing ambitious timelines, enhanced coordination and integrated review by Ethics Committees in all participating Member States. The broader objective is to provide greater predictability for sponsors, strengthen confidence in the European regulatory system and improve the EU’s ability to attract strategic clinical research investment.

During a special Heads of Medicines Agencies (HMA) meeting on 26 November, consensus was reached between 14 Member States to launch the FAST initiative at the end of January 2026. Belgium, represented by the Federal Agency for Medicines and Health Products (FAMHP), confirmed its participation in the pilot scheme.

“Belgium will be willing to act both as Reporting Member State (RMS) and as Concerned Member State (CMS),” the FAMHP told Euractiv. According to the agency, the exact operational details will be developed in the coming weeks in the run-up to the launch date.

The CMS is “a European Economic Area country in which an application has been submitted for authorisation of a medicine through the mutual recognition or decentralised procedure,” the EMA clarifies. The RMS performs the assessment of the medicine.

The agency made clear that the EU initiative will operate in parallel with Belgium’s national strategy.

“This FAST initiative is complementary to the previously announced mononational acceleration projects that Belgium will launch from 8 January 2026.”

Fast-track reform
Belgium is preparing a comprehensive overhaul of its national clinical trial authorisation timelines. From 1 January 2026, the FAMHP will introduce accelerated procedures for the assessment of initial applications for trials with medicines for human use. This measure will allow clinical research to start faster, to the benefit of the patient, and strengthen Belgium’s top position as a centre for clinical trials.

The reform significantly shortens evaluation periods for mononational trials across all phases and introduces specific accelerated pathways for advanced therapies and biotechnological medicines. “This will result in a reduction of timelines to 27 days per application, dependent on the type of dossier,” the FAMPH told Euractiv.

Accelerated timelines
The new Belgian system introduces differentiated timelines depending on the type and phase of the clinical trial.

For mononational Phase I, Phase I/II and Phase II trials, the validation phase will be completed within five days. The evaluation and decision phase will take a maximum of 15 days, extended to 39 days where additional information is requested. For advanced therapy medicinal products (ATMPs) and certain biotechnological medicines, a further extension of up to 10 days may apply.

For mononational Phase II/III, Phase III, Phase III/IV and Phase IV trials, validation will be finalised within seven days, with evaluation and decision-taking up to 28 days. Where additional information is required, this can extend to 57 days, again with a possible 10-day extension for ATMPs and specific biotech products.

Belgium will also implement accelerated timelines for multinational trials under its national pilot scheme when acting as a reference member state. In these cases, validation will take seven days, followed by a maximum evaluation and decision period of 28 days, extendable to 57 days if supplementary information is requested, with the same potential 10-day extension for ATMPs and certain biotechnological medicines.

Faster European coordination
By aligning its domestic acceleration strategy with the emerging FAST-EU framework, Belgium is effectively positioning itself at the intersection of national reform and European coordination. The approach reflects a broader shift within the EU towards reducing administrative bottlenecks, strengthening regulatory predictability and ensuring that Europe remains globally competitive in clinical trials.

Further operational details on FAST-EU will be communicated through the Heads of Medicines Agencies in the coming weeks, as participating Member States prepare for the pilot’s official launch at the end of January 2026.