First Clinical Trial Approved Through New EU Portal
The EU’s new trial portal and database system, which allows the submission of a single application to conduct a study across any number of EU countries, has yielded its first fruit in the form of an approval for a non-commercial Swedish clinical trial involving cardiac arrest patients.
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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.
Notably more clinical trial applications were submitted to the new Clinical Trial Information System in July compared with previous months, according to new data that also shed light on how many submissions have been approved or rejected.
A senior EMA official says Europe has set the ball rolling on presenting a unified approach on clinical trial processes and strategic matters, and is taking steps to ensure there are no roadblocks.