The Clinical Trials Regulation, Regulation (EU) No 536/2014, harmonises how clinical trials of medicinal products are authorised and supervised across the European Union. It applied from 31 January 2022, replacing the earlier Clinical Trials Directive, and introduced a single entry point called the Clinical Trials Information System (CTIS). Through CTIS a sponsor submits one application for a trial that may run in several member states, and the member states carry out a coordinated assessment. The regulation strengthened transparency, with much trial information made public, and set common rules on safety reporting and inspections. Good Clinical Practice, the international quality standard for designing, conducting, and reporting trials, continues to apply. A transition period required all ongoing trials to move to the new framework.
What is the EU Clinical Trials Regulation?
The EU Clinical Trials Regulation (EU) No 536/2014 harmonises the authorisation and oversight of clinical trials across the EU through a single portal.
What is CTIS?
CTIS, the Clinical Trials Information System, is the single EU portal and database used to apply for, assess, and supervise clinical trials under the Clinical Trials Regulation.
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