Sponsors Urged To ‘Push Back’ On EU Country-Specific Clinical Trial Requirements
It has been over five months since the EU Clinical Trial Regulation introduced harmonized requirements for approving new studies. A top European Commission official says that trial sponsors need to keep driving this message home to member states, who are clinging on to their national requirements out of habit.
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The EU guideline on the Clinical Trials Regulation has been updated with a list of member state websites where sponsors can find information on national requirements for trial applications.
Sponsors keen on a specific EU member state to lead the assessment of their proposed multinational clinical trial are being urged to keep the concerned national competent authority in the loop before submitting the dossier to the Clinical Trial Information System.
The European Commission wants to ensure that the content of dossiers filed under the EU Clinical Trial Regulation is harmonized to simplify the trial approval process. Any national requirements imposed by member states should have a clear legal basis.