PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance
Project Scope |
|---|
This project will focus on gathering feedback from our PHUSE Community on the new guidance to accompany the MHRA’s updated clinical trials regulations and how it is written. |
Problem Statement |
|---|
On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK. New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency (MHRA)’s updated clinical trials regulations which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. External stakeholders who wish to share feedback on the newly published guidance are asked to provide their submissions to the HRA. This PHUSE project seeks to obtain and collate stakeholder feedback ahead of the deadline on 10 September to provide comments. All responses will be anonymous. There will also be opportunities throughout the review period to join an open discussion about providing flexibility in the way members share their feedback. |
Problem Impact |
|---|
The MHRA’s regulations cover a wide range of topics and therefore will impact on multiple stakeholders in our cross-functional clinical trials landscape. The opportunity to provide feedback will help further evolve and shape the newly published guidance, driving the future of clinical trials. |
MHRA Guidance |
|---|
On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to The Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK. New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency’s (MHRA) updated clinical trials regulations, which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. Key areas of the regulations are summarised below: External stakeholders who wish to share feedback on the newly published guidance are asked to provide their submissions to the HRA. PHUSE has become the industry voice to regulatory agencies and standards organisations such as the FDA, EMA and CDISC. We value these relationships and partnerships. Our PHUSE Community is comprised of subject-matter experts across the globe within the field of healthcare, and involvement in this initiative will be very beneficial in driving forward the future of clinical trials. |
Project Leads | |
|---|---|
Devaki Thavarajah, Independent | |
Lucy Marks, PHUSE Senior Project Coordinator |
Current Status (Updated Quarterly) |
|---|
|
Objectives & Deliverables | Timelines |
|---|---|
MHRA feedback. | September 2025 |