Medicines and Healthcare products Regulatory Agency (MHRA) - Statement regarding the new Clinical Trials Framework (from Catapult's regulatory round-up for December 2024)

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament on 12 December 2024. When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials regulation in over 20 years, addressing the sector's need for a more efficient and adaptable regulatory framework. The amended regulatory framework will aim to speed up trial approvals and encourage innovation in trial design without compromising patient safety...