The Health Research Authority (HRA) is working in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) to amend the Medicines for Human Use (Clinical Trials) Regulations 2004.
The goal is to create a modern, streamlined regulatory environment that maintains high standards of participant safety while accelerating access to innovative treatments.
Feedback from a public consultation in 2022 helped shape proposals to improve how clinical trials of investigational medicinal products (CTIMPs) are run in the UK. These changes aim to make the UK one of the best places in the world to conduct clinical research.
The updated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025are now effective (28 April 2026).
Please see below a guidance document created by Nottingham Clinical Trials Unit Quality Assurance Team.
