January 26, 2015
EMA launched the adaptive pathways pilot project in March 2014. The adaptive pathways approach – formerly known as adaptive licensing – is part of the Agency’s efforts to improve timely access for patients to new medicines. The concept of adaptive pathways aims to achieve early approval of a medicine for a restricted patient population based on small initial clinical studies. Following review and discussion with companies, the EMA selected 6 therapeutic products from 34 applications. The selected medicines will be further discussed with all stakeholders, including health technology assessment (HTA) bodies and patients’ representatives.