EMA Investigates Potential of Adaptive Pathways

December 17, 2014

Applied Clinical Trials

As of November 2014, the European Medicines Agency (EMA) had received and assessed 29 applications as part of its pilot project on adaptive pathways, formerly known as adaptive licensing.

As of November 2014, the European Medicines Agency (EMA) had received and assessed 29 applications as part of its pilot project on adaptive pathways, formerly known as adaptive licensing. Nine of these applications had been selected for discussion with the applicant.

EMA launched its pilot project in March 2014 to explore this approach with real medicines in development. Stage I of the pilot scheme will close at the end of February 2015. Stage II of the project will include in-depth, face-to-face meetings with the applicants. After February 28, 2015, the agency will still consider new applications for stage II face-to-face meetings if they are well developed.

EMA is planning to publish a report on initial experience gained as part of the pilot project by the end of 2014. The agency recently changed the name of its pilot project from adaptive licensing to adaptive pathways to better reflect the idea of a life-span approach to bring new medicines to patients with clinical drug development, licensing, reimbursement, and utilization in clinical practice, and monitoring viewed as a continuum.

The concept of adaptive pathways foresees an early approval of a medicine for a restricted patient population based on small initial clinical studies, according to an article co-authored by members of the EMA and published in Clinical Pharmacology and Therapeutics. The first approval is followed by progressive adaptations of the marketing authorization to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies.

Applicants should contact EMA at adaptivepathways@ema.europa.eu for advice on the content and suitability of their request to be considered for stage II of the pilot.

 

Read the full release here.

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