In a report published today, the Commission, the national authorities, ethics committees, the European Medicines Agency and stakeholders analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory landscape.
The next steps of this project will investigate developing some of the proposed solutions.
Sponsors will ultimately benefit from a reduced administrative burden, making Europe more attractive for investment and research.
Patients will always be at the heart of this project, as they will have faster access to more innovative and personalised treatments.
Background
Combined studies are studies in which medicinal products are assessed together with medical devices or in vitro diagnostics.
With patients as the ultimate beneficiaries, the COMBINE project is an EU initiative addressing combined studies. The purpose of the project is simple: to streamline regulatory processes and cut the time needed to get innovative and personalised treatments to patients.
The COMBINE project was initiated to address the issues linked to the operational interface between three EU regulations:
- Clinical trials regulation;
- Medical devices regulation;
- In vitro diagnostic medical devices regulation.
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