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MHRA pilot to prepare sponsors for clinical trial regulation changes

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The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pilot scheme to streamline the approval process for certain changes to clinical trials.

The move comes ahead of new UK clinical trials regulations that will come into force next year and aims to ease the transition process for study sponsors.

The new regulation will see major modifications become eligible for automatic approval through the Route B substantial modification process, such as those eligible under section 11B of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

Sponsors enrolled in the pilot, which runs from 1 October 2025 to 31 March 2026, will receive a response from the MHRA within 14 days. They also can familiarise themselves with the eligibility criteria. 

As part of this transition, the current voluntary notification scheme for Type A trials will end on 30 September. Under the new regulations, this scheme as well as the ‘new notification scheme’ will be merged into ‘Notifiable Trials’. 

Eligible sponsors can register for the pilot here. 

Streamlining clinical trial regulations

The pilot is being rolled out to help prepare for new clinical trials regulations coming into force on 28 April 2026, which aim to provide an ‘agile, innovative, and patient-centered’ framework”

The pilot is being rolled out to help prepare for new clinical trials regulations coming into force on 28 April 2026, which aim to provide an “agile, innovative, and patient-centered” framework.

Commenting on these upcoming regulations on Clinical Trials Day 2025, Lawrence Tallon, MHRA Chief Executive, said: “The reforms will address the research sector’s need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible.”

A joint analysis on the UK’s clinical trial landscape published earlier this year by the MHRA and University of Liverpool highlighted the “strong innovation” found within the country’s research environment. As part of this it surveyed UK clinical trials submitted between 2019 and 2023 and found that one in eight trials tested treatments were first-in-human studies.

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