The UK’s clinical research environment is changing, and quickly. Recent updates from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) show a drive to make the system faster, clearer and more consistent, while keeping the same high standards for safety and quality.
The MHRA has cut the average time to approve a clinical trial from 91 days to just 41. That’s a huge step forward, supported by new digital systems, a more proportionate review process and operational changes across the agency. Analysis published in the British Journal of Clinical Pharmacology found that 99% of applications are now reviewed within statutory timelines, with most completed well ahead of schedule.
To help researchers and sponsors prepare for what’s next, the HRA has released its final guidance for the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which will take effect on 28 April 2026. The updated regulations aim to make trial setup and delivery more efficient, reduce unnecessary admin, and bring greater consistency across the review process.
Some of the key updates include:
- A Combined Review service, bringing together ethics and regulatory review within a single coordinated process.
- Simplified consent options, in defined circumstances, to reduce administrative burden while maintaining participant safety and understanding.
- New legal requirements for research transparency, including trial registration, publication of summary results (typically within 12 months), and lay-friendly result summaries.
- Updated pharmacovigilance requirements for CTIMPs, simplifying safety reporting routes and timelines.
- An expectation – currently proposed in the forthcoming legislation – that trials recruit their first UK participant within two years of approval, unless exemptions apply.
To prepare for these changes, the MHRA is also running a pilot from October 2025 to March 2026, offering 14-day regulatory decisions on eligible or lower-risk trial amendments. This will help test and refine the faster notification process that’s due to become standard under the new framework.
At MAC Clinical Research, we welcome these changes. We’re ready to help Sponsors adapt to the new system and make the most of a more streamlined, predictable environment for clinical research in the UK.
