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Time Running Out To Switch Ongoing Studies To EU Clinical Trials Regulation

 
• By Vibha Sharma

Industry and academic study sponsors have called for an urgent solution to address the administrative burden and the short timeframe remaining to move their ongoing trials authorized under the EU Clinical Trials Directive to the Clinical Trials Regulation.

Young businessman thinks over the steps for successful growth: Clinical trial
There will be no legal ground for studies approved under the Clinical Trials Directive to continue after 31 January 2025 • Source: Shutterstock

The implementation of the EU Clinical Trials Regulation over the past year and a half has been riddled with challenges for sponsors and regulators alike as it represents a major change in processes for submitting and evaluating study applications.

Key Takeaways

  • Sponsors of ongoing clinical trials authorized under the erstwhile EU Clinical Trials Directive must switch their studies to the Clinical Trials Regulation if these trials are not expected to end by 30 January 2025.

While sponsors are still grappling with mandatory compliance to CTR provisions for new trials as of 31 January 2023, there...

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