MHRA’s Innovative Licensing and Access Pathway initiative is now live

The Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that as of 01 January 2021, their new Innovative Licensing and Access Pathway (ILAP) for accelerated drug development is open to applicants.

This pathway has been created with the aim of reducing the time to market for innovative medicines such as new chemical entities, biological medicines, new indications and repurposed medicines, whilst simultaneously improving patient access. The programme will provide opportunities for enhanced regulatory input from stakeholders including:

  • National Institute for Health and Care Excellence (NICE)
  • Scottish Medicines Consortium (SMC)
  • National Health Service (NHS)
  • Health Research Authority (HRA)
  • National Institute for Health Research (NIHR)

Initially, developers should apply for an Innovation Passport. The Innovation Passport is the mandatory entry point to the ILAP and includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope.

Following this, a Target Development Profile (TDP) should be created that outlines a road map for the product that defines both the key regulatory/development features along with the identification of any possible issues. The TDP step can only be accessed via the Innovation Passport, therefore an Innovation Passport application should be approved prior to this.

It is important to note that the ILAP does not replace the Early Access to Medicines Scheme (EAMS). The ILAP is geared towards accelerating the development through the early-mid stages whilst the EAMS enables earlier patient access towards the end of the development cycle in order to satisfy areas of unmet medical need. Consequently, applicants can apply for both the Innovation Passport required for the ILAP and the Promising Innovation Medicine (PIM) designation of the EAMS.

More detailed information regarding the ILAP scheme can be found here.