EMA launches adaptive licensing pilot

The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases.

The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines. It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.

“With the adaptive licensing pilot project we intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients to new medicines that address serious conditions with unmet medical needs,” explains Hans-Georg Eichler, the Agency’s Senior Medical Officer. “The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access for patients with the need to provide adequate evolving information on their benefits and risks.”

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