Spring Intro 2023

22/03/2023

What is the EU Clinical Trial Regulation?

The EU Clinical Trial Regulation streamlines the clinical trial application process & increases transparency

The new EU Clinical Trial (CT) Regulation (No 536/2014) will replace the current CT Directive (2001/20/EC) Overall aim is to create an environment favorable to conducting CTs in the EU, with the highest standards of participant safety and increased transparency • Standardize the Clinical Trial Application (CTA) process • Information on authorization, conduct, and CT results in the EU to be publicly available Implementation will occur over 3 years:

31 JAN 2022 : Optional for all trials

31 JAN 2023 : Required for new trials

31 JAN 2025 : Required for all trials

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New Procedure for Clinical TRIALS in EU

Regulatory Application (Part I) • Single assessment by lead ‘Reporting’ Member State (MS), other MS provide input during coordination phase • 60-day assessment timeline (+50 days for advanced therapies / novel medicines) • One single round of questions, short 12-day deadline for responses = need to be nimble and strategic in dealing with these • Single regulatory outcome (yes / no) applying to all MS Ethics Committee Assessment (Part II) • Remains national • Same assessment deadlines, single list of questions as above

Reduced complexity for initial submission (1 submission, 1 assessment), but greater planning and preparation needed to ensure success

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