Xtalks | EU Clinical Trial Regulation: Latest Developments and Upcoming Opportunities
The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, 2022, and sponsors now need a clear view of how the framework is operating in practice and where it may evolve next. This webinar explores the current status of clinical trial regulation in the EU, including experience with Clinical Trial Information System (CTIS), updated transparency expectations and emerging regulatory developments.
Since CTIS launched, nearly 13,000 initial applications have been submitted, giving sponsors substantial experience with the benefits and challenges of a more harmonized system, a centralized submission portal and revised transparency rules. Key guidance materials, including the CTIS Sponsor Handbook and related support resources, continue to be updated, with a further handbook update published in March 2026.
The webinar will examine the European Commission’s Biotech Act proposal, published on December 16, 2025, and its potential implications for the future EU clinical trial framework. Topics include reduced assessment timelines, parallel substantial modifications, new trial categories, dossier and Member State concepts, emergency procedures and combined trial pathways through CTIS.
You will gain practical context on current submission and transparency expectations, ongoing operational challenges and potential future opportunities in the evolving clinical trial regulatory environment in the EU.
