Key points:

• Common technical document (CTD) to Clinical Trial Regulation (CTR) transition: Although 80% of trials intended for transition have been submitted, there are still clinical trial applications (CTAs) requiring transition with a timeline for transition of about 49 days, which are extending well beyond the published 22-day expedited Clinical Trials Coordination Group timelines. Nevertheless, sponsors are at risk of lawsuits or sanctions in the event of non-compliance
• The CTR Collaborate vision focuses on the harmonisation of procedures across EU member states and between regulators and ethics committees (ECs). Whether this will address the mounting sponsor challenges of disharmonised national requirements, inflexibility of the Regulation and the clinical trials information system (CTIS) remains to be seen

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