Thursday, January 22, 2015

Adaptive licensing (AL) – The new approach towards effective drug development and regulation

European Medicines Agency’s (EMA), Adaptive Licensing (AL) is an approach towards improving the timely access in drug regulation and development. Innovative treatments would always be surrounded by uncertainty and questionability, states EMA. As compared to the traditional system, Adaptive Licensing helps with an early license, granted at the initial stage having less clinical info through Randomized Controlled Trials (RCTs).

Once, initial license is arranged, entry to the market is strictly restricted and patient population is also carefully monitored with the help of observational readings, registries and electronic devices. The monitored data from the RCTs and post-license surveillance study is used to conclude full license permission. Patient access time and the overall cost can be reduced by refining the orientation of stakeholder needs. However, questionability still exists and the political and cultural changes would play a major role in understanding the potentials of adaptive licensing.

Big Market Research adds a report titled “Adaptive Licensing - A Holistic Approach to Drug Development and Regulation.” The report provides detailed analysis of the various dynamics of the adaptive licensing including introduction, strengths, proponents, precursors, future of adaptive licensing, legality, value-at-risk, etc.

Adaptive licensing is currently a fresh debate as EMA has invited many drug developers to embroil in pilot projects. By far, EMA has accepted two pilot projects and 11 are under consideration. Adaptive licensing is a vast approach which includes staggered approval, conditional licensing, progressive authorization and Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs).

The report on adaptive licensing help the readers with extensive information on the AL approach. It would help in better understanding of the strengths, opportunities and weaknesses of the adaptive licensing system for both new and established businesses. 

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