New legal requirements for clinical trials came into force on the 28 April 2026.
Together, the Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) have developed amended regulations that have been shaped by – and will benefit – patients, researchers, health professionals, and industry.
The updated regulations are designed to protect trial participants, strengthen patient safety, and accelerate approvals by reducing unnecessary burdens on researchers, to support high-quality, trusted research taking place in the UK.