New UK Pathway Use Has ‘Far Exceeded Expectations’
Early/Mid-Development Stage Drugs Accounted For Most 1st-Year Requests
Oncology products accounted for the largest proportion of requests for a UK “innovation passport” last year, with a wide variety of drug sponsors deciding to use the new ILAP, according to the UK regulator, the MHRA.
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The Evolution Of Drug Regulation In Post-Brexit Britain
Regulatory reliance is playing an increasingly important role in gaining marketing authorization in the UK following Brexit. Meanwhile, the country’s unique Innovative Licensing and Access Pathway is attracting growing levels of interest, not just from companies but from regulators and health technology appraisal bodies across the world.
UK Offers To Help ‘Innovation Passport’ Holders Tackle Market Access Challenges
The option of receiving early, joined-up advice from HTA bodies in England, Scotland and Wales is among several tools that companies can use if their product is admitted to the UK’s Innovative Licensing and Access Pathway.
UK Regulator Issues 41 ‘Innovation Passports’ In First Year Of New Pathway
The UK’s ILAP, a post-Brexit scheme introduced in 2021 to accelerate the development of, and access to, new innovative medicines, proved popular in its first year of operation. A total of 71 applications were received last year from companies wanting to take advantage of the regulatory advice, tools and flexibilities on offer.