New UK Clinical Trials Regulation enters into force

The Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025 entered into force in the UK on 28 April 2026. The Regulations amend the existing Medicines for Human Ise (Clinical Trials) Regulations 2004. The purpose of the new Regulation is to protect trial participants, strengthen patient safety, and accelerate clinical trial approvals by reducing unnecessary burdens on researchers. The revisions include introduction of a Combined Review process that permits researchers to seek ethics and regulatory approval together. The Regulation also introduces a legal requirement to i) register clinical trials involving medicinal products in a public registry, ii) publish a summary of trial results within 12 months of completion and, iii) to offer to share a summary of results with participants (or other relevant people) in a way they can easily understand. Trial sponsors who meet certain conditions may use simplified arrangements for seeking and evidencing informed consent of trial participants.

The MHRA has published a number of related guidance documents to assist sponsors and investigators in understanding and fulfilling their related obligations.