June 2026
Serbia's ALIMS has launched an Agency-operated national clinical trials registry; the EU's HMA Clinical Trials Coordination Group has published a revised list of national contact points under Regulation 536/2014; Slovakia's SUKL has clarified a 50% electronic filing fee reduction for applications filed electronically; and the EU's EMA has updated the CTIS Sponsor Handbook to version 6.3, introducing an opt-in email notification system for Notices and Alerts.
Serbia ALIMS National Clinical Trials Registry Launched (28-May-2026)
The Medicines and Medical Devices Agency of Serbia (ALIMS) have launched the National Clinical Trials Registry, a centralized, Agency-operated public platform for reviewing and searching data on approved clinical trials conducted in Serbia. It is searchable by trial name, therapeutic area, status, sponsor, and healthcare facility, and includes an interactive map of trial locations. The registry does not change disclosure requirements in Serbia or introduce any new sponsor registration or results-disclosure obligations.
European Union CTR National Contact Points List Updated (12-Jun-2026)
The HMA Clinical Trials Coordination Group has published a revised list of national contact points under Regulation (EU) 536/2014. Belgium's registered address and contact email domain have been updated, Estonia's national contact point has changed, and the European Medicines Agency observer has been revised.
Slovakia SUKL Electronic Filing Fee Reduction Clarified (22-Jun-2026)
SUKL has issued a notice clarifying that, under Section 6(2) of Act No. 145/1995 Coll. on Administrative Fees, clinical trial applications submitted electronically or through a certifying person qualify for a 50% fee reduction, capped at EUR 50. The reduction applies automatically where all documents in the procedure are filed electronically.
European Union CTIS Sponsor Handbook Updated to Version 6.3 (26-Jun-2026)
The EMA published version 6.3 of the CTIS Sponsor Handbook. Key changes include a new opt-in email notification system for Notices and Alerts, replacing the previous monitoring-only model, and expanded Article 11 guidance permitting partial submissions with placeholder Part II data under defined conditions, including a France-specific restriction. The update also incorporates CTR Q&A v7.2 and refreshed cross-references.
