Post-Brexit clinical research regulation in the UK: what's changed, what's coming, and what it means for your trials
Post-Brexit clinical research regulation in the UK: what's changed, what's coming, and what it means for your trials
Until 2021, an EMA approval effectively meant a UK approval too. The MHRA, then part of the European regulatory network, followed the centralised procedure's outcome without running its own review. That relationship is gone, and the gap keeps widening, alongside a wider NHS push toward digital, traceable regulation.
What's changed
Combined Review. Since 28 April 2026, the MHRA and the Health Research Authority assess CTIMP applications together instead of in sequence, cutting UK trial set-up from 169 to 122 days.
Mandatory transparency. For the first time, sponsors must register a trial on a public registry before recruitment begins and publish results within 12 months of completion. Skipping either is now an offence.
Risk-proportionate review. Lower-risk trials and Phase I studies now move through lighter, faster pathways, including a modification route that averaged seven days in pilot.
What's coming
The MHRA is also writing the ICH's newer GCP standard, E6(R3), and its study-design guideline, E8(R1), into UK law, pushing trial design toward more adaptive, patient-centred models.
A UK path that runs beside the EU's, not inside it. Since the International Recognition Procedure replaced the temporary EMA-linked route in 2024, an EMA approval is one option among seven, not a default, and the UK still sits outside the EU's Clinical Trials Information System.
What it means for your trials
If a study only runs in the UK, this is mostly operational: build the new deadlines and Combined Review into your process. The complexity shows up once a study runs in the UK and Europe together.
The two systems no longer share one clock. The UK's Combined Review timeline runs independently of the EU's CTR and CTIS timeline, so a delay on one side no longer maps onto the other. Registration has split too: a UK registry entry doesn't satisfy the EU's requirement, and vice versa. A dual-market trial now means two registrations, two results deadlines, and potentially two reference regulators for the same product.
That doesn't make running trials in both markets impossible, but the UK can no longer ride on an EU submission's schedule by default. It needs its own line in the project plan.
That same logic holds even without an EU trial running alongside. The NHS's own reforms are pushing UK submissions to move faster and become more traceable, and ResearchManager's platform is built to support exactly that: streamlining how a UK-only study handles regulatory documentation, TMF management, and site approvals in one place.
For studies that also run in the EU, that same platform carries the added complexity of tracking two registrations and two timelines.
If it'd help to talk through where your studies stand: are you running Phase I, II or III trials, do they involve investigational medicinal products or devices, and are you active in both the UK and the EU? Happy to compare notes.
Contact
Contact us via https://my-researchmanager.com/en/ or hans@myresearchmanager.com
Our previous content
- Why setting up a clinical trial still feels like starting from scratch every time
- The hidden cost of running clinical trials on spreadsheets and email chains
- Why clinical research in England takes twice as long as it should, and what is actually causing the delay
- Introducing: ResearchManager – accelerating Clinical Research