EU Clinical Trial Sponsors Reassured On Member State Dossier Requirements
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.
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New Guidance To Clarify Transparency Provisions In EU Clinical Trials Portal
EU regulators have developed new guidance to help companies steer through the transparency requirements in the Clinical Trials Information System and protect personal and commercially confidential information in submissions.
Centralized Templates To Help Harmonize Trial Dossiers Requirements Across The EU
Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.
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.