MHRA launches pilot program to test automatic changes to clinical trials
Medical product sponsors can apply for a pilot program launched by the UK’s Medicines and Healthcare Regulatory products Agency (MHRA) that allows them to make certain changes to their clinical trials automatically without resubmitting their application. The pilot is intended to help the agency and medical product manufacturers learn what changes can be made to clinical trials automatically as part of a new regulatory framework that goes into effect next year.Earlier this year, the UK Parliament approved new clinical trial regulations expected to go into effect in April 2026. The regulations were developed in partnership between MHRA and the Health Research Authority (HRA) and are intended to be a more streamlined regulatory framework.
In preparation for the new framework, MHRA announced on 27 August that it is launching a pilot program that will operate between 1 October 2025 and 31 March 2026. The program will allow pilot participants to make certain changes to their clinical trials that the agency will review and respond to within 14 days.
“The pilot will expand the MHRA’s risk-proportionate approach to include the review of modifications to approved clinical trial applications,” said the agency. “Under the new regulations, substantial modifications can be granted automatic approval through the Route B substantial modification process, providing they meet eligibility criteria.”
“As part of the transition to the new regulatory framework, the existing voluntary notification scheme for Type A trials will close on 30 September 2025,” the agency added. “Type A trials involve medicinal products licensed in any EU Member State, and relate to the licensed range of indications, dosage, and form.”
MHRA said it is expanding its current risk-proportionate approach to clinical trials to also include changes to approved clinical trial applications. Under the new framework, substantial modifications in clinical trials that meet pre-defined criteria will automatically be approved through the agency's Route B substantial modification process without the need for companies to reapply.
"This process will need to be followed by everyone submitting an eligible modification to a clinical trial," said MHRA. "Draft guidance supporting the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 is available on the Clinical Trials Hub.
"The section on modifying a clinical trial covers the Route B substantial modifications criteria," the agency added.
MHRA announcement
