EMA develops adaptive pathways for new medicines
The European Medicines Agency (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.
The pilot project, which has now ended, showed that adaptive pathways can bring multiple stakeholders together – regulators, health technology assessment (HTA) bodies, healthcare professionals and patients – to agree on a prospective plan to generate data on a medicine across its lifespan in areas of unmet medical need. Adaptive pathways can support medicine development in therapeutic areas where evidence generation is challenging, such as infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.
Source: EMA Press Release, 3 August 2016.