EMA communication: Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia

EMA 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 organisations 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 authorised by a regulatory authority. This is a way of making new treatment options available to patients.

As part of the pilot, 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.

Candidate medicines for the pilot should fulfil the following criteria:

• contain a well-established active substance;
• be an authorised medicine (containing the concerned active substance) out of data exclusivity and market protection periods and out of basic patent / supplementary protection certificate (SPC) protection;
• target an indication in a condition distinct from the currently authorised indication(s);
• target an indication in an area where important public health benefits are likely to be achieved. Conditions for which no or few medicines are currently authorised or which are associated with high morbidity and / or mortality despite available medicines, will be the focus of the pilot.

Eligible academia sponsors developing orphan medicines will automatically benefit from a fee waiver. Additional fee waivers will be granted to a subset of selected applications taking into account the extent of the expected public health benefits and the strength of the evidence to substantiate the promise held by the proposal.

Further information on the pilot project is available in a question-and-answer document .

Sponsors wishing to seek EMA scientific advice should complete the drug repurposing submission form and submit it to sarepurposing@ema.europa.eu by 28 February 2022.

Please note that repurposing of medicines for COVID-19 falls outside the scope of this pilot project.

Deadline: 28 February 2022.