CASMI

‘From Adaptive Licensing to Adaptive Pathways’ paper has been published in Clinical Pharmacology & Therapeutics

policy and impact

Scientists argue that scientific and political changes will make adaptive pathways the preferred approach to make new treatments available.

“Adaptive pathways should be the preferred approach in the near future to bring new medicines to patients.” A number of scientists, including members of the European Medicines Agency (EMA) and its scientific Committees take this position in a co-authored article published in Clinical Pharmacology and Therapeutics.

The paper is available on the Clinical Pharmacology & Therapeutics website.

The concept of adaptive pathways foresees an early approval of a medicine for a restricted patient population based on small initial clinical studies. The first approval is followed by progressive adaptations of the marketing authorisation to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies.

EMA launched a pilot project on adaptive pathways (formerly known as adaptive licensing) in March 2014 to explore this approach with real medicines in development.

As of November 2014, the Agency had received and assessed 29 applications as part of the pilot, nine of which had been selected for discussion with the applicant.

Stage I of the pilot project will close at the end of February 2015. The Agency will then focus on stage II of the project. This will include in-depth, face-to-face meetings with the applicants for the applications selected.

After 28 February 2015, EMA will still consider new applications for stage II face-to-face meetings if they are well-developed. Applicants are invited to 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.

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