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EMA launches adaptive licensing pilot project

The European Medicines Agency (EMA) is now inviting companies to participate in its adaptive licensing pilot project.

Any company who is interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases, states the agency in a press release. 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.

“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,” said 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.”

The EMA further states that it intends to include as many programmes as necessary in this pilot phase in order to gather sufficient knowledge and experience, address a range of technical and scientific questions and further refine how the adaptive licensing pathway should be designed for different types of products and indications.