Welcome to the July 2023 issue of Clinical Trials Highlights.

We are now mid-way through the transition period of the Clinical Trials Regulation (CTR), 18 months after the launch of the Clinical Trials Information System (CTIS). In total, over 1700 initial clinical trial applications have been submitted in CTIS and over 700 clinical trials (CTs) authorised under the CTR are available in the system.

Building on the CTR, the vision of the ACT EU initiative is to make the EU more attractive for clinical research. ACT EU aims to enable more impactful, fit for purpose CTs, with seamless coordination among regulators and impacted stakeholders. The initiative envisions smart CTs through regulatory, technological and process innovation. The new clinical trial ecosystem will foster collaboration by empowering, engaging and supporting stakeholders to deliver better medicines to patients.

As part of the initiative, the kick-off meeting of the ACT EU multi-stakeholder platform took place in June, with broad participation from sponsors, regulators, including ethics committees, academia, patients and healthcare professionals. A series of workshops are planned in 2023 and 2024 to establish the platform and further discuss identified priorities.

Better clinical trials bring medicines to patients faster. We are strongly committed to working with stakeholders towards an excellent environment for CTs in Europe, with smarter, more impactful CTs that deliver high quality clinical evidence for better public health.

Bjorn Eriksson
Director General
Swedish Medical Product Agency