The European Medicines Agency has received 20 applications so far as part of its adaptive licensing pilot project. Following an in-depth review of nine of these applications, the Agency has selected the first two medicines to be included in the pilot. A further four applications are potential candidates for the pilot and may be considered at a later stage. The other three applications were not considered suitable for the pilot and the remaining eleven are currently being evaluated. 

This is the first wave of medicine development programmes to be considered for this project and the Agency continues to accept applications from interested companies.

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 that address serious conditions with unmet medical needs. 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 for increasingly broader patient populations. 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 Agency launched its adaptive licensing pilot project in March 2014 to explore with real medicines development programmes how adaptive licensing can be implemented.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002119.jsp&mid=WC0b01ac058004d5c1