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Legislation to speed up clinical trials has come into force across the UK, under what the government has described as “the largest package of reforms in over 20 years”.
On 27 April 2026, the government said that the new combined approval process “takes an average of 41 days, less than half of the time it took a few years ago”.
Developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), the legislation takes effect from 28 April 2026.
Under the new legislation, researchers will be able to simultaneously apply for ethics and regulatory approval for new clinical trials of investigational medicinal products.
“Latest figures show the contribution of the MHRA and HRA reducing set-up times from 169 days to just 122 days for studies going through combined safety and ethical review,” the government said.
In the NHS ‘Fit for the future: ten-year health plan for England’, published in July 2025, the government pledged to speed up clinical trial recruitment, noting that “by March 2026, clinical trials setup time will fall to 150 days”.
The legislation also allows for faster approval of requests to modify a clinical trial under some circumstances, where the modification does not introduce significant new safety concerns. These requests — under the Route B substantial modification pathway — can now be looked into with a “risk-proportionate review instead of a full assessment”, the government said.
In a blog published on 27 April 2026, the MHRA‘s clinical trials team said that the aim had been “to cut the time it takes us to review applications from 35 to 14 days”, adding that during a pilot of the Route B pathway, the average time had actually been seven days — “well below the 14-day threshold and significantly shorter than a standard substantial amendment”.
Lawrence Tallon, chief executive of the MHRA, commented: “These reforms will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research. Most importantly, patients will benefit from earlier access to the latest, innovative medicines.
“We have listened carefully to the needs of patients, clinicians, researchers and industry to ensure we are delivering the most efficient, streamlined approvals process without compromising safety.”
