Clinical Trials Regulations – What you need to know

New Clinical Trials Regulations Guidelines The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 represent the most significant overhaul of UK clinical trials regulation in two decades. Signed into law on 11 April 2025, these regulations take full effect from 28 April 2026, following a 12-month implementation period designed to help sponsors prepare for […]

MHRA Notification Scheme

The UK Clinical Trial sector is due to benefit from a recently launched MHRA notification scheme for certain types of initial Clinical Trial Applications (CTAs).  This marks the start of an MHRA overhaul of UK clinical trial regulations. The scheme will see the lowest-risk clinical trials processed in less than 14 days (reduced from 30 […]

Clinical Trial Regulation (CTR) – A Closer Look

Clinical Trial Regulation (CTR)   From 31st January 2023, it will no longer be possible to submit new initial clinical trial applications under the Clinical Trials Directive.  It will also no longer be possible to add new Member States (MS) to existing trials approved under the Directive without first transitioning to the new Clinical Trial […]