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EU Helps Sponsors To Steer National Fee Requirements Under Clinical Trials Regulation

 
• By Vibha Sharma

A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.

Clipboard, woman and scientist writing in laboratory for medical research on cancer drug trial. Checklist, investigation and female biologist with clinic protocol development for pharmaceutical study
EU Regulators Want To Increase The Bloc’s Attractiveness For Clinical Trials (Shutterstock)
Key Takeaways
  • The Clinical Trials Coordination Group (CTCG), which works under the EU Heads of Medicines Agencies to harmonize and optimize the clinical trials regulatory environment, has issued a consolidated document on member state fee requirements for submissions under the EU Clinical Trials Regulation (CTR).
  • The initiative forms part of ongoing efforts to simplify the clinical trial application process for sponsors by offering better visibility on national requirements.
  • The CTCG has also revised its key template for the cover letter required for initial submissions or resubmissions of new trial applications in the Clinical Trials Information System.
  • The group has also updated its Q&A document on safety reporting requirements to clarify annual safety report submissions and the use of a risk-based approach for safety recording and reporting within the CTR.

The EU Clinical Trials Coordination Group (CTCG) has collected in one place the fee requirements prescribed by different member states in the European Economic Area (EEA) pertaining to submissions under...

The consolidated document, published on 14 January, is part of broader efforts in the EU to make it easier for trial sponsors to navigate the national processes relating to...

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