EMA modernizes trial system to make EU more attractive for studies

The European Medicines Agency (EMA) has announced a plan to modernize the clinical trial information system (CTIS) and redesign the training materials for the sponsors and CROs that use the drug study database.

The Amsterdam, Netherlands-based drug regulator shared details of its modernization plan this week after a meeting of its management board and ahead of the publication of its annual activity report later this month.

According to the EMA, “Since its launch in 2022, the Clinical Trial Information System (CTIS) has received over 11,300 initial applications, with more than 9,300 authorised by EU Member States.”

The agency added that, “Simplifying CTIS business rules remains a key priority, and a roadmap for modernising the system is currently under development.”

The CTIS has been operational since 2022; however, it only became fully functional in January after the EU Clinical Trials Regulation (CTR) came into effect.

ACT EU

The EMA also provided an update about the Accelerating Clinical Trials in the European Union (ACT EU) initiative – a programme launched in 2022 to develop the EU as a competitive centre for innovative drug trials.

The EMA wrote, “Upcoming milestones include the finalisation of the redesign of CTIS/CTR training materials for trial sponsors and the planned publication of key performance indicators to assess the attractiveness of the EU for clinical research, as well as the speed and impact of clinical trials across the EU.”

The comments are in keeping with the ACT EU work plan the EMA announced in December.

At the time, the EMA said tracking the performance of the European clinical trials environment through reporting and re-organisation of training material and guidance documents on CTR/CTIS to help users access content were priorities.

In March, the ACT EU initiative saw the EMA launch a study identification tool for patients and healthcare professionals.

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