MHRA have launched a new route for approval of medicines in the UK; the Innovative Licensing and Access Pathway (ILAP) which is operational from the 1st of January 2021.
The objective of this new pathway is to provide a platform for collaborative working between developers, authorities and regulatory bodies, reducing the time to market for a wide range of medicines undergoing development, including Advanced Therapy Medicinal Products (ATMPs), medicines for rare diseases and repurposed medicines.
The ILAP pathway is open to both commercial and non-commercial developers of medicines and allows entries very early in the development programme. It does not replace the Early Access to Medicines Scheme (EAMS) but is promoted to be broader in scope and open to all innovative medicinal products.
With ILAP, there will be a new medicine designation: the Innovation Passport*, which triggers the MHRA and partners to create a Target Development Profile (TDP)* – a living document which sets out a product-specific roadmap towards patient access in the UK healthcare system.
To read more about this new approval process go to: https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap-for-medicines/about-the-pathway or our email our expert team to learn how we can support your applications in the UK asktheexperts@ndareg.com
*Fees apply