Clinical Trials in Belgium

Belgium, a small country making a major impact on global clinical research

Belgium is one of Europe’s leading hubs for clinical research, particularly in early-phase and first-in-human trials. Over the past five years, it consistently ranked #2 in Europe for clinical trial authorisations per inhabitant.

This performance is built on a robust clinical research ecosystem combining world-class hospitals, research centres, experienced investigators, and specialized life sciences logistics networks.

Global biopharmaceutical leaders have chosen Belgium

The biopharmaceutical industry accounts for around 80% of all clinical trial authorisations (CTAs), reflected in the presence of every major global pharmaceutical company.

Despite representing only 2.6% of the EU population, Belgium accounts for 17% of European oncology trials, 18% in immune system diseases, 12% in nervous system disorders, and 14% of pediatric clinical studies. Close cooperation between industry, hospitals, and research institutions supports high-performance trials across multiple therapeutic areas and vaccines.

Combining speed, expertise, and regulatory reliability

Belgium offers a highly efficient regulatory framework led by the Federal Agency for Medicines and Health Products (FAMHP), a European reference in early-phase clinical research.

From 2026, the FAMHP introduces accelerated evaluation timelines for clinical trial applications, targeting 20 days for mono-national Phase I–II trials.

Scientific and Technical Advice, early regulatory dialogue, and strong representation within EMA and HMA working groups further de-risk innovation, reinforcing Belgium’s position as one of Europe’s fastest and most reliable regulatory environments.

The Belgian Association of Clinical Research Organizations (BECRO) complements this framework, ensuring operational excellence across all phases of clinical development.