EMA launches adaptive licensing pilot project

EMA launched an adaptive licensing pilot project under which the agency will grant early approval to some products in a restricted patient population. According to the agency, the early access would be followed by "iterative phases of evidence gathering" and the expansion of the product's authorization to broader patient populations. EMA said submitted products should address an unmet need and should be in the early stages of development, which the agency said is prior to confirmatory studies and normally includes testing "during or prior to Phase II." The agency did not set a target number of products for the pilot and said it "intends to include as many programmes as necessary." ...