EU regulators have issued guidance explaining what the next steps are for sponsors who moved their ongoing studies that were approved under the erstwhile Clinical Trials Directive (CTD) to the Clinical Trials Information System (CTIS) on the basis of a “minimum dossier.”
The minimum dossier mechanism was introduced in July 2023 to make it easier for sponsors to switch their trial registrations to CTIS, as required by the Clinical Trials Regulation (CTR),...
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