On 28 April 2025, the United Kingdom (UK) Parliament and Northern Ireland Assembly approved the The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004 which currently govern the regulation of clinical trials involving investigational medicinal products (CTIMPs) in the UK.
The changes to the regulations are based on feedback from a public consultation in 2022, which included input from various stakeholders on beneficial changes to the existing legislation.
While Parliament has approved the updates, the new regulations will not come into force until 28 April 2026. This means that CTIMPs will continue to follow the Medicines for Human Use (Clinical Trials) Regulations 2004 until 27 April 2026.
The existing guidance on the HRA website will give you up to date information on how you should submit, manage and conduct CTIMPs in compliance with the 2004 regulations.
When the new regulations do come into force, they will apply across all four nations of the UK (England, Wales, Scotland and Northern Ireland). All clinical trials taking place in the UK will be required to comply with the updated regulations.
To help you understand and prepare for the new requirements, we have developed guidance that outlines the following changes:
- definitions and terminology
- research transparency requirements for clinical trials
- the approvals process for clinical trials
- Research Ethics Committees that review clinical trials
- simplified arrangements for consent in clinical trials
- pharmacovigilance
This guidance sets out the changes to the REC and MHRA review process for CTIMPs in line with the new clinical trials regulations.
It does not detail any other review processes CTIMPs may need, such as HRA and Health and Care Research Wales (HCRW) Approval. This is because only the REC and MHRA review process for CTIMPs is within the remit of the clinical trials regulations and is directly impacted by the updated legislation.
There will be some changes to how non-CTIMP applications are processed and managed based on the changes brought in by the updated regulations. This will help make sure there's better process alignment between CTIMPs and non-CTIMPs. We'll share separate guidance and information ahead of these changes coming into force.
MHRA guidance
We also recommend you read the guidance produced by the Medicines and Healthcare products Regulatory Agency (MHRA) to help you understand what will change when the new regulations come into force.
Good clinical practice (GCP) for clinical trials
The updates to the clinical trials regulations will include changes to Part 4 (GCP and the conduct of clinical trials) of the existing legislation.
This will include introducing a legislative requirement for CTIMPs to comply with the conditions and principles in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice.
Most of these changes will apply to all CTIMPs from 28 April 2026, regardless of whether they were submitted before or from this date. For further information, read the MHRA's transitional arrangements guidance.
The MHRA will be producing detailed guidance further explaining the changes relating to GCP conduct for clinical trials in the coming months.