Medical Treatments: Innovation

The Medicines and Healthcare products Regulatory Agency (MHRA) plays a vital role in delivering the Government’s Life Sciences Vision and wider Plan for Change by enabling earlier and broader patient access to innovative treatments. The agency’s ambition is to be a world-leading, innovation-enabling regulator that accelerates the availability of safe, effective products without compromising patient safety.

The MHRA supports the development and availability of innovative medicines through a range of regulatory initiatives designed to enable earlier patient access while maintaining uncompromising standards of safety. Central to this is the Innovative Licensing and Access Pathway (ILAP), which offers a joined-up approach between the MHRA, the National Institute for Health and Care Excellence, and National Health Service bodies including within the Devolved Administrations. ILAP provides early regulatory input through an “Innovation Passport” and a tailored roadmap to authorisation, helping promising new medicines reach patients more quickly.

Innovators can access early scientific advice and regulatory engagement to help de-risk development and support high-quality applications. By providing expert guidance at the pre-submission stage, the MHRA helps developers navigate complex regulatory pathways.