The Belgian Federal Agency for Medicines and Health Products accelerates clinical trial evaluations to boost access to innovative treatments

On 14 October 2025, the AFMPS announced new accelerated evaluation timelines for clinical trial applications to enable faster access to innovative treatments in Belgium. For sponsors and CROs, this means faster study start-up, shorter regulatory lead times, and enhanced predictability.

1. Streamlined timelines for mononational clinical trials

From January 2026 onward, clinical trial applications conducted solely in Belgium (“mononational trials”) will benefit from significantly shorter review timelines:

• Phase I, I/II, and II trials: evaluation within 20 days after submission (or up to 59 days if additional information is requested).
• Phase II/III, III, III/IV, and IV trials: evaluation within 35 days (or up to 79 days with a request for additional information).
• For Advanced Therapy Medicinal Products (ATMPs) and certain biotechnological medicines, a possible extension of 10 days applies.

These deadlines are roughly 50% shorter than current timelines. Phase I trials already benefited from fast-track evaluation, but this expansion provides a consistent accelerated pathway across early and late clinical phases.

2. Pilot phase for accelerated multinational trials

The AFMPS is also launching a pilot phase for accelerated evaluation of multinational clinical trials (Phases I, I/II, and II), when Belgium acts as the reporting Member State under the EU Clinical Trials Regulation.

Under this pilot:

• Applications will be evaluated within 35 days after submission, or 79 days when additional information is required.
• A 10-day extension may apply for ATMPs and certain biotech medicines.
• The accelerated timeline will be applied upon request from the sponsor and subject to agreement among the Member States involved.

This approach reflects Belgium’s proactive stance in ensuring efficient cross-border coordination for innovative therapies under the European regulatory framework.

3. Summary of accelerated timelines

4. Looking ahead

Belgium is reinforcing its role as a high-performance regulatory environment for clinical development. The AFMPS’s acceleration plan provides sponsors and CROs with a competitive operational edge, enabling them to start studies faster, access innovative therapies earlier, and strengthen Belgium’s standing as a gateway for European clinical research.

Authored by Hélène Boland and Fabien Roy.