www.fdanews.com/articles/179062-uk-report-proposes-new-designation-for-accelerated-access-to-medicines
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UK Report Proposes New Designation for Accelerated Access to Medicines
October 28, 2016
The British government is granting a new accelerated pathway for treatments likely to provide a significant benefit.
Dubbed the transformative designation, the accelerated market pathway would provide drug sponsors guidance on navigating the market and reaching the appropriate patient populations.
The proposed designation would rely on this collaboration between sponsors and regulators and build on the country’s programs for breakthrough therapies, such as the European Medicines Agency’s PRIME and the UK’s Early Access to Medicines Scheme, which focus on the approval of products, but not their marketing.