Clinical trial approvals go into fast-forward

🚀 Big news from Belgium: clinical trial approvals go into fast-forward!

Starting1 January 2026, the Belgian Federal Agency for Medicines and Health Products (FAMHP) will cut clinical trial approval timelines in half — positioning Belgium among the fastest regulators!

These accelerated timelines will allow clinical research to start sooner, bringing innovative treatments faster to patients, without compromising on quality or safety.

💡 Why does this matter?

With these new timelines, the FAMHP strengthens Belgium’s position as one of the most competitive and attractive locations for clinical research worldwide, boosting both patients’ access to innovation and the national R&D ecosystem.

✨ What's new?

1) Faster decisions for mononational trials

2) A pilot for accelerated multinational assessments, when Belgium acts as Reporting Member State (RMS)

Together, these initiatives confirm Belgium’s leadership as European hub for speed, quality, and regulatory excellence!

🧾 Summary of accelerated timelines (from 1 January 2026): see image attached

⚡The bottom line: This is more than an administrative tweak — it’s a game-changer for sponsors, researchers, and patients.

In Belgium, we're setting the pace.