National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics.
The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials and medical devices, as well as the Commission, European Medicines Agency, ethics committees and stakeholders such as sponsors, clinicians, and patient representatives.
Among the goals of this programme are to:
- Pilot a single assessment process for multi-country combined studies across device and medicinal product regulations
- Harmonise serious adverse event reporting processes
- Clarify questions on the interface between clinical trials and medical device regulations
- Explore new opportunities for advising sponsors and facilitating knowledge exchange among national authorities
The strategy can be found on the Commission’s webpage: Combined studies and COMBINE strategy
COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.
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Source: European Commission | Public Health | In the spotlight (https://shorturl.at/NFYcW)