Good News For Sponsors Of Combination Studies Involving Both Drugs And IVD Medical Devices

• Published date: 29 January 2024
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Plesner
• Author: Mette-Marie Buch Henrichsen

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...