The Medicines and Healthcare products Regulatory Agency (MHRA) opened a new Innovation Passport application window Monday, giving experimental drug developers a way to coordinate with UK health authorities as they plan evidence for potential patient access.
An Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP). Through the pathway, developers work with the regulator, bodies that assess medicines for public health systems and the National Health Service (NHS) on plans for further development.
The designation provides guidance while a treatment remains under investigation. It does not make a drug available to patients. Later access decisions would require assessments of clinical evidence and value.
The MHRA has used the pathway for medicines targeting different conditions. In August, it granted an Innovation Passport to BeOne Medicines Ltd.’s investigational liver cancer drug BGB-B2033. That was a development designation, not a decision to provide the drug to patients.
The current application window opened Nov. 9 and closes Feb. 11, 2027.
