Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment
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Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment
Regulatory Affairs In Vitro Diagnostics
Monday, 23 June 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 13 June 2025, the European Commission, together with EU Member States and the European Medicines Agency (EMA), launched the first phase of the COMBINE Project 1 pilot—a one-stop, coordinated assessment process for combined clinical trials of medicines and performance studies of companion in vitro diagnostic (IVD) devices.
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Launch of the first phase of the COMBINE Project 1 | Regulatory Update
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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.
Learn more on the European Commission website
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.
Get in touch with our experts
Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.
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