The ILAP and the Aligned Pathway – What’s the difference?

The Innovative Licensing and Access Pathway (ILAP) and the MHRA-NICE Aligned Pathway both support earlier patient access to safe and effective medicines but they serve different purposes and are accessed at different points in development. The ILAP provides early, coordinated development and access support, while the Aligned Pathway brings together the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) decision-making timelines.

As both involve engagement with the MHRA and NICE, developers often seek clarity on how they fit together in practice. This blog sets out what each pathway is for, how they differ, and how they may be used together across a product’s development.

At a glance: the ILAP vs. the Aligned Pathway How these pathways are accessed

To enter the ILAP, developers apply for an Innovation Passport via the ILAP registration portal.

To access the Aligned Pathway, developers must register on UK PharmaScan at least 3 years before expected MAA.

How the ILAP and the Aligned Pathway fit together

The ILAP is accessed earlier in development, and products in the ILAP may go on to use the Aligned Pathway at the appropriate stage.

The ILAP supports developers to plan development and align evidence generation, which can help prepare for the timelines and requirements of the Aligned Pathway.

Visual comparing the ILAP and the MHRA–NICE Aligned Pathway and showing how the Aligned Pathway fits within an ILAP product’s journey. Scientific Advice services

Both the ILAP and Aligned Pathway offer opportunities for joint scientific advice to support alignment between regulatory and HTA evidential requirements. However, they differ in scope and use.

ILAP Joint Scientific Advice (JSA):

Exclusive to the ILAP Is used in place of Integrated Scientific Advice for ILAP products Provides pan-GB advice from the MHRA, the HTA bodies NICE, AWTTC and SMC Accessed following development of a Target Development Profile (TDP) which helps determine optimal timing and prepares developers for engagement Designed to support development planning and evidence generation

Integrated Scientific Advice:

Open to all medicines, regardless of Aligned Pathway participation Particularly relevant for products intending to follow MHRA and NICE Aligned Pathway timelines Provides advice from MHRA and NICE Accessed at developer’s discretion, particularly key in the design of pivotal trials, or bridging the gap between regulatory and HTA requirements through early access schemes See our guidance for submitting an integrated scientific advice request Key takeaways The ILAP is accessed earlier and provides coordinated, sustained support for development and access planning, evidence generation, and system navigation, including input from across the UK health system. The Aligned Pathway is accessed later and coordinates MHRA and NICE decision-making timelines. The two offers are complementary and can be used at different stages of a product’s lifecycle. Contact us

ILAP queries: InnovationPassport@MHRA.gov.uk

Aligned Pathway queries: presubmission@mhra.gov.uk

https://medregs.blog.gov.uk/2026/06/24/the-ilap-and-the-aligned-pathway-whats-the-difference/

seen at 16:54, 24 June in MedRegs.