New UK Clinical Trials Law – A Streamlined Approach

From 28 April 2026, the UK is changing how clinical trials are approved and run — with one clear aim: make research quicker, less bureaucratic, and more proportionate to risk.

The headline change? One application, one combined review. Instead of separate regulatory and ethics decisions, trials will be assessed together, cutting duplication and delays. While timelines can still run up to 107 days, many studies are expected to move much faster.

For low‑risk trials, there’s an even quicker option. A new notification‑based pathway means eligible studies can be automatically approved within 14 days — across all trial phases.

The whole system is becoming more risk‑based. Lower‑risk studies face lighter oversight, while higher‑risk trials still receive full scientific and ethical review. Regulators will also rely more on existing evidence, including real‑world data and decisions from trusted international authorities.

Day‑to‑day trial management should also be easier. Changes to studies are now called “modifications”, with fewer notifications and approvals required for routine updates.

There are modernising touches too: simplified consent for some low‑risk trials, a wider range of professionals able to act as investigators, and a legal requirement to be transparent — including registering trials and sharing plain‑English results with participants.

In short, these changes are about removing friction without compromising safety — and making the UK a more attractive place to run clinical research.

Here is a breakdown of the changes that are coming into force:

1. New rules start on 28 April 2026

The new regulations apply to all UK clinical trial applications submitted on or after 28 April 2026. Ongoing trials will also need to move over to the new system, with set transition arrangements to help with the change.

2. Faster and simpler approvals

The Combined Review is now written into law. This means there’s just one application, reviewed at the same time by the MHRA and HRA.

• The standard approval timeline is up to 107 days, but in many cases it’s expected to be much quicker (around 40 days).
• Some low risk studies can use a notification only route.
• These Notifiable Trials get automatic approval within 14 days, as long as they meet the eligibility criteria.

3. A more risk based approach

The new system focuses regulatory effort where it’s really needed:

• Lower risk trials get lighter oversight and faster decisions.
• Higher risk trials still go through full scientific and ethical review.

Regulators will also make greater use of:

• Real world data
• In silico data (for example, computer modelling and simulation results)
• Evidence from trusted international regulators

4. New language for trial changes

The term “amendment” is being replaced with “modification”, which comes in different types:

• Substantial modification – Route A Full MHRA/HRA assessment needed.
• Substantial modification – Route B Automatic approval within 14 days if eligibility criteria are met.
• Modification of an important detail Notification required, but no formal approval.
• Minor modification No notification needed. These just need to be recorded and submitted later if required.

Some changes won’t need approval at all, such as notifying first participant recruitment or a change of sponsor.

5. Ethics, consent and investigators

There are a few important shifts here:

• Simplified consent is allowed for certain low intervention trials.
• A wider range of professionals can act as investigators, not just doctors.
• There’s more emphasis on proper training, supervision, and clearly defined roles.

6. Transparency is now a legal requirement

For the first time, transparency is written into law. Sponsors must:

• Register trials before the first participant is recruited (or within 90 days of approval).
• Publish a summary of results within 12 months of the global end of the trial.
• Offer results to participants in plain English.

Some deferrals are allowed, including an automatic 30 month deferral for Phase I trials in healthy volunteers.

7. Labelling, manufacturing and systems

Other updates include:

• New guidance on labelling for IMPs and non-IMPs. (Investigational Medicinal Products)
• GMP (Good Manufacturing Practice) requirements are largely unchanged — business as usual.
• IRAS (Integrated Research Application Systems) will stay in use for now, with a new digital system planned for rollout in 2026–27

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