The Clinical Trials Regulation (CTR) came into force in the EU on 31st of January 2022 once CTIS became openly accessible to the general public. The aim of the CTR is to harmonize and simplify the initial application and surveillance process for clinical trials across the EU. The CTR and its Guidelines for different processes throughout the life-cycle of the clinical trial can be found on the European Commission webpage.
Under the new Clinical Trials Regulation, all clinical trial applications as well as revisions and other changes to ongoing clinical trials must be filed through the Clinical Trials Information System (CTIS).
After the Regulation was adopted by the European Parliament in April 2014, GCT’s Regulatory and Legal Affairs teams began preparing for the changes, while using both local Clinical Trial Application (CTA) procedures and the Voluntary Harmonisation Procedure (VHP) for applicable trials.
We have prepared detailed reviews of the Clinical Trials Regulation, as well as of the Medical Devices Regulation (MDR), which also became recently applicable on the 26th of May 2021. Reach out to GCT at bd@gctrials.com to receive the reviews and to find out whether you as a Sponsor need to take additional actions for transitioning the ongoing study.