MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and Access Pathway (ILAP) with a new tool for health technology assessments (HTA).
Innovative Licensing and Access Pathway
Innovative Licensing and Access Pathway (ILAP) aims to speed up the time to market, thereby providing patients with more access to medicines. New chemical entities, biologics, and new indications are all included in this category.
A steering group comprised of partners oversees ILAP activities, which include making recommendations about A steering group comprised of partners oversees ILAP activities, which include making recommendations about Innovation Passport (IP) applications.
(IP) applications is an innovation passport that enables the creation of a "target development profile," which is a "roadmap" for a product's development using a variety of regulatory tools and flexibilities.
Health Technology Assessments (HTA) tool aims to promote understanding of the market access approaches that will optimize the route to patient access. This tool is best suited to products that may have complex HTA and commercial challenges, radical changes to an established care pathway, and significant changes in infrastructure, training, and workforce.
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