Sponsors can now submit a single application for trials involving both a medicinal product and its companion diagnostic, across multiple EU countries.
The pilot aims to streamline authorisation timelines, reduce duplication, enhance transparency, and apply harmonised evaluations across participating Member States.
Expressions of interest are open until 31 August 2025; selected sponsors will be notified by 31 October.
What does this mean to you?
If you're active in pharma or IVDs, this pilot could drastically simplify the authorisation process: fewer submissions, less administrative burden, and quicker approvals of combined studies.
For clinical researchers and device sponsors, this means faster patient access to innovative treatments and greater regulatory efficiency across EU borders.
If you’re considering a combined study, now is the time to act. As your Legal Representative, we can help you prepare your submission, coordinate with the authorities, and support your response to the call for interest before the 31 August deadline.
Reach out today to explore how we can assist you in making the most of this opportunity.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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