European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation

27 Mar 2023

The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.

Overcoming challenge and obstacle concept. Flat vector illustration — The interplay between the IVDR and the Clinical Trials Regulation Poses Challenges • Source: Shutterstock

The European Commission is taking steps to ensure that ongoing challenges posed by the implementation of the In Vitro Diagnostic Regulation (IVDR) does not cause unintentional delays to drug clinical trials that are to be run in combination with IVD studies.

Concerns on this front were highlighted in a recent survey by the European industry federation for research-based drug companies, EFPIA....