Life Science

Clinical Trials in Belgium

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

Belgium is recognized as one of Europe’s leading hubs for clinical research — consistently ranked #2 in Europe for clinical trial authorisations per inhabitant over the past five years.

Preferred destination for studies

Global biopharmaceutical leaders choose Belgium as a preferred destination for their studies. The biopharmaceutical industry accounts for around 80% of all clinical trial authorisations (CTAs) in the country.

Strong ecosystem

Belgium’s success is built on a robust clinical research ecosystem, combining world-class hospitals, research centres, and specialized logistics networks. This ecosystem is supported by a favourable and efficient regulatory framework, led by the Federal Agency for Medicines and Health Products (FAMHP), ensuring fast and reliable trial approvals. Beginning in 2026, the FAMHP will introduce accelerated evaluation timelines for clinical trial applications, further strengthening Belgium’s reputation as one of Europe’s fastest and most reliable regulatory authorities

Cooperation

Close cooperation among hospitals, research institutions, and industry supports studies across
multiple therapeutic areas and vaccines. The country shows a particularly strong presence in
oncology (18% of all EU cancer trials), immune system diseases (16%), nervous system diseases
(12%), and paediatric studies (14%) – far exceeding its 2.6% share of the EU population.

Cooperation

With rare diseases representing over 20% of national trial authorisations, Belgium continues to advance medical innovation and improve patient outcomes worldwide. The Belgian Association of
Clinical Research Organizations (BECRO) further enhances this ecosystem, bringing together
leading CROs that ensure operational excellence and high-quality support throughout every
phase of clinical development.

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