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A Reflection on the European Regulatory Framework

May 10, 2024

Historically gaining regulatory approval across multiple countries within the European Union (EU) was segmented, excessively bureaucratic, and challenging to navigate. Sponsors had to submit clinical trial applications separately to national competent authorities (NCA) and ethics committees (ECs) in each country to gain regulatory approval to run a clinical trial. Individual countries dictated their own set of national submission requirements and gave local opinions on the trial design.

The result of inconsistent feedback left Sponsors with the challenge of unifying recommendations within a single global protocol often leading to multiple protocol amendments or country-specific versions of the master protocol. These challenges subsequently resulted in inflated costs and long start-up timelines and the perception that the EU was a difficult place to run clinical research.

Read more about the Catalyst Oncology approach to the EU clinical trial process. Stay tuned for an upcoming column about some of the challenges we’ve solved for our Sponsors with the Clinical Trials Information System (CTIS).