Here At Last: A New Era For Clinical Trials In The EU
A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.
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A senior executive at the European Medicines Agency says that all major technical problems with the EU Clinical Trials Information System are close to being resolved, and will free up time to focus on delivering much needed improvements and new functionalities.
Research-based drug companies are asking for swift implementation of UK clinical trial reforms to ensure the country does not lose out on commercial trial activity amid challenges such as capacity constraints in the NHS and delays in regulatory approvals.
At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.