Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines Agency has released a document to address the most frequently asked questions from companies and to clarify the terms of engagement and expected outputs for prospective applicants.

The document clarifies in particular:

• The criteria used by the Agency to select suitable candidates for the pilot project
• The concrete steps involved in the process and expected outcomes
• The context and aim of the exploratory discussions between the Agency and selected candidates

The Agency launched its adaptive licensing pilot project in March 2014 to explore how adaptive licensing can be implemented with real medicine development programmes.

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.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/09/news_detail_002167.jsp&mid=WC0b01ac058004d5c1