The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines
February 28, 2022
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).
Source: FAMHP
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 agencies, 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 medicines agency which will select mature applications at pre-entry phase which are then allowed to proceed to the scientific advice phase of the pilot.
More information
Questions and answers document
Application form