Regulating Clinical Trials
This POSTnote describes the new EU Clinical Trial Regulation and the timetable for its implementation and examines its likely impact on the regulation of clinical trials in the UK post-Brexit.
DOI: https://doi.org/10.58248/PN561
Clinical trials are essential to establish the safety and efficacy of medicines and are strictly regulated in the EU. The current EU regulatory framework is due to be replaced by a new EU Clinical Trial Regulation in 2019. This POSTnote examines how this may effect the UK healthcare industry, including issues around clinical trial transparency. It also examines options for UK regulation of clinical trials post-Brexit, including a brief description of the more general issues facing UK patients and clinical researchers post-Brexit.