EMA pilot to support not-for-profits and academia in repurposing meds

The European Medicines Agency and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines as a follow-up to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework.

The aim of this initiative is to support not-for-profit organizations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication with the view to have this new use formally authorized by a regulatory authority. This is a way of making new treatment options available to patients, the EMA noted.

As part of the pilot, the EMA and the national medicines agencies will provide regulatory support, primarily scientific advice, to help these stakeholders generate a data package robust enough to support a future application by a pharmaceutical company.