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.
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NHS England has committed to two pilots on innovative pricing models for advanced therapies under the UK’s new voluntary pricing agreement for new medicines.
NICE has provisionally turned down three products for funding under the National Health Service in England: Sanofi’s Rezurock for chronic graft-versus-host disease, Sobi’s lymphoma drug Zynlonta, and AstraZeneca/Daiichi Sankyo’s Enhertu for the new indication of HER2-low breast cancer.
The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.