In the month of March the European Medicines Agency (EMA) launched its adaptive licensing pilot project.
So what is Adaptive licensing...
Adaptive licensing is a new approach to licensing medicines, which is still in the early stages of development. In this model, licensing is based on stepwise learning under conditions of acknowledged uncertainty, data and regulatory evaluation. This is in contrast to traditional drug-licensing approaches, where an experimental therapy is transformed into a fully evaluated therapy at the moment of licensing.
The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is aimed at improving timely access for patients to new medicines especially when there are no satisfactory alternative therapies. Adaptive licensing builds on existing regulatory processes and intends to extend the use of elements that are already in place, including scientific advice, centralised compassionate use, the conditional marketing authorisation 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. Ongoing medicine development programmes submitted by companies should be experimental medicines in the early stage of clinical development, i.e., prior to the initiation of confirmatory studies.
This approach could allow approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions.
AL will take into consideration impressive preliminary animal/human data; positive benefit risk; commitment of sponsor to conduct further studies after initial MA; adequate infrastructure to observe AL etc. Thus AL is designed to manage the entire life span of a drug, during which data continue to be generated on the product through various ways, including active surveillance and additional studies after initial and “full” licensing.
Refer below link for more information.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/03/news_detail_002046.jsp&mid=WC0b01ac058004d5c1
