Clinical trials are the cornerstone of medical innovation, driving the development of new treatments and therapies that improve patient outcomes and advance healthcare. However, the traditional clinical trial process is often lengthy and complex, posing significant challenges for researchers, sponsors, and patients alike. The COVID-19 era brought a decrease in multi-state clinical trials applications in the EU. In response to this, in 2022, the European Union Accelerating Clinical Trials in the EU (ACT EU) launched two pilot projects. In this coordinated effort between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission (EC, these pioneering initiatives aim to increase the focus of clinical trials across Europe making the market more competitive.
The two pilots went into effect on June 10, 2024, with the first offering manufacturers scientific advice when conducting clinical trials and how to successfully manage applications for market authorization. The groups hope to help streamline the process and avoid discrepancies.
In the second of the two pilots, which will be managed by the Clinical Trials Coordination Group (CTCG), sponsors of market applications will benefit from the use of the CTCG’s Clinical Trials Information System (CTIS) to learn about issues regarding the clinical trial application portion of their premarket dossier. The upside is that applicants can receive pre-submission technical and regulatory support as a consolidated view from Member States represented at CTCG that oversee clinical trial applications when prior to this pilot, only the Member State reviewing the application would provide such feedback.
Read more about these pilots here.
