Good news for sponsors of combination studies involving both drugs and IVD medical devices

A new application process and accompanying guidance will hopefully make it easier to get started with such studies.

The Danish Medicines Agency and the Danish Committees on Scientific Ethics have jointly prepared a new guidance for a new national coordinated application process for clinical trials of medicinal products and performance studies for in vitro diagnostic devices (IVD) in combination studies. 

So far, the Sponsor has had to go through separate application processes for (a) authorisation for the clinical trial of medicinal products and (b) authorisation for certain performance studies of IVD devices. 

To ease the challenging process, the application procedure has been optimised with a coordinated assessment that ensures that the Sponsor receives simultaneous decisions for the clinical trial and the performance study. The national coordinated application process is possible when Denmark is involved in a mononational or multinational clinical trial in CTIS.

The guidelines for the coordinated application process for combination programmes in Denmark can be read here (in Danish).

Please note that the Danish Medicines Agency has invited all stakeholders to submit input and questions to the Agency, see here (in Danish)

Want to know more?

If you would like to know more about the above or have any other questions about clinical trials of pharmaceuticals and medical device trials, please contact Plesner's Life Science team. 

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