The interim results from the ACT EU pilots on consolidated scientific and regulatory advice have been published and available to stakeholders. These pilots were launched to offer harmonised advice on how to improve the quality of applications for clinical trials and marketing authorisation.
📑 Read the report here
The interim report highlights clear benefits for applicants, including advice for improved study design and greater clarity on regulatory expectations. These elements can support smoother clinical trial applications with potentially fewer issues raised during their assessment. Applicants also reported a strong willingness to reapply, reflecting the value of the pilots for early planning and streamlined submissions.
The pilots remain open to applications in 2026, and further details including how to apply are available on the ACT EU website.