Navigating EU clinical trials: Adapting to a new era of regulations.

Abstract

In recent years, new healthcare regulations have been introduced in the aim of standardising implementation processes across European Union (EU) member states, while maintaining high ethical and scientific standards for healthcare innovation. In clinical research, the simultaneous application of multiple EU regulations to clinical trials poses significant challenges. The interplay between these regulations' requirements is explored. These regulations often overlap in scope but differ in requirem