MPNEsupport Org 802492-1069, Sweden
Melanoma Patient Network Europe
Source: Hans Eichler, EMA, on Adaptive Licensing in March 2012
(These) 'adaptive approaches are all based on the premise that knowledge about medicines is not binary but continues to evolve over time. The proposal is to replace the single transition from non-approval to approval with a series of approval stages with iterative phases of evidence gathering and regulatory evaluation.'
Source: WHO- Priority Medicines for Europe and the World 2013 Update
Hans Eichler, EMA, on Adaptive Licensing in March 2012
Can adaptive licensing bridge the gap between regulatory and HTA evidentiary standards?