The MHRA Innovative Licensing and Access Pathway is open for business
The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). #MHRA #ILAP
gov.uk/government/new…
Innovative Licensing and Access Pathway (ILAP)
"A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access." #MHRA #ILAP
gov.uk/guidance/innov…
Geron Enters New Innovative Licensing and Access Pathway in the United Kingdom for Imetelstat #MHRA #ILAP $GERN [I am not an investor in $GERN]
finance.yahoo.com/news/geron-ent…
"The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines.
Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National…
…Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans."
Further: "The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England.
To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative…
…medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients.
The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones.
Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review.
The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement."
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