EMA adaptive pathways pilot project

By William Chin, PhD, Scientific Coordinator, EUCRAF

Regulators and scientists at the European Medicines Agency (EMA) as well as from other regulatory agencies, academia and industry have recently published an article in Clinical Pharmacology and Therapeutics, stating their position on the adaptive pathways of drug approval. The consensus is that the adaptive pathways should be the preferred approach for approval of medicinal products in the future. The article is a result of the multi-stakeholder collaboration under the New Drug Development Paradigm initiative (NEWDIGS) of the MIT Center for Biomedical Innovation. 

In the article, the authors stated that the new treatments could reach to certain patient population based on a small preliminary evidence through adaptive licensing. Through the advancement of scientific understanding of pathologies, the identification of subgroups of patients who are likely to better respond to certain medicines than others is now feasible. Economic pressure on healthcare systems demands for a more sustainable development program and targeted use of medicines in a better defined populations. These factors have been identified to drive the favorable adoption of the adaptive pathways. 

Back in March 2014, EMA has launched a pilot project on adaptive pathways (formerly known as adaptive licensing). As of November 2014, the Agency had received and assessed 29 applications as part of the pilot project. EMA is planning to publish a report on initial experience by the end of 2014.


1. EMA News and Press Release, 15 Dec 2014, Adaptive pathways: a future approach to bring new medicines to patients?

2. From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients, DOI: 10.1002/cpt.59