UK Kicks Off Landmark Overhaul Of Clinical Trial Framework
Changes Affect Processes, Requirements & Timelines
Executive Summary
The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.