A rise in UK clinical trial applications is being hailed as a sign that the country is on track to become a “global first choice” for clinical research, following a previous uplift in 2024. The MHRA reported a 9% year-on-year increase between January and November 2025, driven largely by growth in early-phase and innovative studies, including healthy volunteer, first-in-human and first-in-UK trials.
Regulators push for speed and agility
The relevation comes as the MHRA prepares to introduce new trial processes from April 2026. These include a notification‑based fast‑track route, expected to cover around one in five lower‑risk studies, and a 14‑day assessment pathway for phase 1 trials. Dr Zubir Ahmed, Health Innovation Minister, said the government is “laser-focused on accelerating clinical trial set-up times and cementing our position as global leaders”, adding that the changes are “making it even easier for companies to bring clinical trials to the UK, offering a single point of support, faster processes, and a more predictable pathway to launch studies”.
Lawrence Tallon, CEO, MHRA, said sponsors “are clear about what they need: speed, clarity and flexibility”, stressing that the “biggest shift is still to come” as new rules make it simpler to initiate lower‑risk studies, strengthen early-stage research and “embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety”.
Industry cautiously optimistic
The ABPI has welcomed the regulator’s figures as a sign that efforts to reverse recent declines in UK trial activity are gaining traction. Dr Janet Valentine, Director of Innovation and Research Policy, ABPI, called the rise in applications “an encouraging sign” that reinforces growth in industry‑led initiations in 2024, and warned that “speed and predictability in regulatory approvals are critical” to delivering on the government’s 150‑day set‑up ambition and sustaining timely recruitment.
The big question for pharma is whether these early-phase wins will translate into an uplift in trial starts and completions. This will be tested at a time when competing hubs in Europe, North America and Asia are also racing to shorten start‑up timelines and attract R&D players. Only time will tell.
