The Medicines and Healthcare products Regulatory Agency (MHRA) is launching a pilot from 1 October 2025 to 31 March 2026 to streamline the approval process for certain changes to clinical trials, as part of preparations for new clinical trials regulations coming into effect on 28 April 2026.

The pilot will expand the MHRA’s risk-proportionate approach to include the review of modifications to approved clinical trial applications. Under the new regulations, substantial modifications can be granted automatic approval through the Route B substantial modification process, providing they meet eligibility criteria.

Changes to notification of Type A trials

As part of the transition to the new regulatory framework, the existing voluntary notification scheme for Type A trials will close on 30 Se

See Full Page