Changes to UK Clinical Trials Regulations Take Effect April 28, 2026. New Versions of UK Model Clinical Trial Agreement Forms Pending.

Who Should Read This Alert

Clinical trial sponsors and all other stakeholders involved in conducting commercial clinical trials of investigational medicinal products (IMP) in the UK.

What You Need to Know

In April 2025, the UK Parliament and Northern Ireland Assembly approved several changes to the Medicines for Human Use (Clinical Trials) Regulations (the CTR), the law governing the regulation of clinical trials involving IMPs in the UK. These changes (the CTR Amendment) will go into effect on April 28, 2026, and will apply across England, Wales, Scotland, and Northern Ireland. The CTR Amendment is part of the UK’s national strategy to promote the UK life sciences sector and streamline its regulatory framework.

The CTR Amendment introduces significant changes to the conduct of commercial clinical trials involving IMPs in the UK. This alert primarily highlights anticipated updates to the UK’s Commercial Contract Model Agreements, which are integral to such trials. Additionally, it provides a summary of other important modifications to the UK clinical trial landscape resulting from the CTR Amendment.

Clinical Trial Agreement and Commercial Contract Model Agreements

As of the date of this alert, the UK’s Health Research Authority (HRA) is reviewing draft changes to the model Clinical Trial Agreement (mCTA) form. This review is part of a broader initiative, including changes to the mCTA prompted by the CTR Amendment. Generally, the mCTA is the agreement form that commercial sponsors are required to use when engaging investigative sites in the UK to perform clinical trials of IMPs. Once finalized, relevant changes to the mCTA will be incorporated into other commercial model agreement forms used for clinical trials in the UK. Accordingly, sponsors should expect updated versions of the mCTA and all other applicable model agreements.

Based on information provided by the HRA, including draft versions of the revised mCTA, changes to the legal terms resulting from the CTR Amendment are expected to be limited.

Notable revisions will include implementation of new and revised terminology, such as updating ”Trial Site” to ”Trial Location” and ”Subject” to ”Participant.” These changes are not expected to fundamentally affect the scope or meaning of the legal terms. However, it is important to note that these terminology updates are more than cosmetic, especially in the context of the broader regulatory framework. For example, the CTR Amendment introduces a new category, ”notifiable trials,” which refers to studies’ meeting specific conditions and presenting no known significant safety concerns with any of the IMPs involved. When a commercial sponsor demonstrates that its study qualifies as a notifiable trial, the sponsor may bypass MHRA assessment (although ethics committee review remains required).

You can also expect that the mCTA and other applicable model agreements will be updated to include terms reflecting new transparency requirements under the CTR Amendment. These changes will address the listing of clinical trials on public registries and the mandatory disclosure of clinical trial results, including providing results to trial participants in an easy-to-understand format.

Summary of Other CTR Amendment Changes

Below is a high-level overview of major changes introduced by the CTR Amendment:

• Revision and addition of defined terms used within the UK clinical trial regulatory framework.
• Codification of the combined regulatory/ethics committee review process.
• Introduction of new transparency requirements, including required trial registry listing and publication of results.
• Simplified approval procedures for certain ”low-risk” clinical trials.
• Alignment of UK Good Clinical Practice (GCP) principles with ICH guidelines.
• Updated safety reporting requirements.
• Amended manufacturing and assembly requirements for IMPs and other products.

How We Can Help

Our integrated team of lawyers and contracts specialists has supported clients in launching hundreds of clinical trials and negotiated thousands of clinical trial-related agreements. We leverage our experience to provide tailored guidance through each stage of the contracting process.

If you are conducting a study under a US IND and need help navigating the clinical trial contracting process in the UK, please contact us.  

Additional Resources

MHRA Guidance -- Medicines: clinical trials hub - GOV.UK

HRA Guidance -- Guidance on changes to the clinical trials regulations - Health Research Authority