The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).
The aim of this initiative is to support non-profit organisations and academia to gather or generate sufficient evidence on the use of an established medicine in a new indication. The goal is to have this new use of the medicines formally authorised by a regulatory authority. This way, new treatment options are made available to patients.
As part of the pilot, EMA and a number national medicines authorities, including the FAMHP, will provide regulatory support, primarily through scientific advice. This will help stakeholders generate a data package robust enough to support a future marketing authorisation application.
The project is 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.
Non-profit organisations and academia can submit their application free of choice either to EMA or a national authority which will select mature applications at pre-entry phase which are then allowed to proceed to the scientific advice phase of the pilot.