Starting January 1, 2026, the FAMHP will implement accelerated timelines for the assessment of initial applications for clinical trials of medicinal products for human use — a major step forward for clinical research in Belgium and beyond.
🔬 What is changing?
🚀 Mononational Phase I–II trials: assessed within 20 days, or 59 days if additional info is requested (+10 days for ATMPs).
🚀 Mononational Phase II/III–IV trials: assessed within 35 days, or 79 days with additional info (+10 days for ATMPs).
🚀 Multinational trials (pilot phase): Belgium as reference Member State can assess Phase I–II trials within 35 days, or 79 days with additional info (+10 days for ATMPs).
These timelines are nearly 50% faster than before — positioning Belgium among the fastest regulators in Europe without compromising quality or safety.
💡Why it matters
This initiative ensures that innovative treatments reach patients faster, strengthens Belgium’s role as a clinical trial hub, and reinforces the FAMHP’s reputation as a reliable and efficient partner in the European regulatory landscape.
As someone deeply committed to improving clinical trial operations and patient access, I see this as a bold and necessary move. It’s a signal to sponsors, CROs, and research institutions: Belgium is ready to lead.
Let’s keep pushing boundaries — for science, for speed, and most importantly, for patients.
#ClinicalTrials #DELTACLINICAL #DCT