EMA Introduces Adaptive Licensing Scheme

The European Medicines Agency (EMA) has launched an adaptive licensing pilot project designed to improve access to new medicines, and is inviting companies to submit ongoing medicine development programs for consideration as prospective pilot cases.

The adaptive licensing approach, also known as staggered approval or progressive licensing, starts with the early authorization of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorization to expand access to the medicine to broader patient populations, according to an EMA statement issued on March 19. The scheme requires the involvement of all stakeholders who have a role in determining patient access, including the EMA, industry, health technology assessment bodies, organizations issuing clinical treatment guidelines and patient organizations.

“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, EMA’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.”

Adaptive licensing builds on existing regulatory processes and intends to extend the use of elements that are already in place, including scientific advice, centralized compassionate use, the conditional marketing authorization mechanism (for medicines addressing life-threatening conditions), patients’ registries and pharmacovigilance tools that allow collection of real-life data and development of risk management plans, the EMA stated.