EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients' unmet medical needs. In March 2014, EMA launched the pilot project to explore the practical implications of the adaptive pathways concept with medicines already under development. It is not a new route of marketing authorization; it makes use of existing regulatory tools. Under this approach, the medicine is first authorized in a small patient population that is likely to benefit most from the medicine. Then, additional evidence is gathered over time, resulting in progressive licensing adaptations to extend or restrict the previously authorized indications of the medicine. During the pilot, EMA received 62 applications, 18 of which were selected for in-depth, face-to-face meetings with the participation of other stakeholders. At the end of the pilot, six of these applications had progressed to receive formal parallel advice by EMA and health technology assessment bodies and one to benefit from simple scientific advice.
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