MPNEsupport Org 802492-1069, Sweden

Melanoma Patient Network Europe

Source: ​Hans Eichler, EMA, on Adaptive Licensing in March 2012

Definition

(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 

​

Adaptive Licensing

reading

Hans Eichler, EMA, on Adaptive Licensing in March 2012

Can adaptive licensing bridge the gap between regulatory and HTA evidentiary standards?

​