Industry news

European Medicines Agency Launches Adaptive Licensing Pilot Project

To improve timely patient access to new medicines, the European Medicines Agency (EMA) launched a pilot project that employs an adaptive licensing approach to real medicines in development.

Adaptive licensing, sometimes called staggered approval or progressive licensing, is a prospectively planned process, starting 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.

As a holistic approach, adaptive licensing requires the involvement of all stakeholders with a role in determining patient access: the EMA, industry, health technology assessment bodies, organizations issuing clinical treatment guidelines and patient organizations.

The EMA is inviting companies to participate in this project by submitting their ongoing medicine development programs for consideration as prospective pilot cases.

For more information, including an application and a framework document to guide discussions of individual pilot studies, see http://www.ema.europa.eu/