A new initiative from the European Medicines Agency aims to support organisations investigating potential secondary uses for pre-existing medications
The European Medicines Agency (EMA) and the international network of Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of medicines.
The initiative aims to support not-for-profit and academic organisations to gather or generate sufficient evidence on the use of an established medicine in a new indication, with the view to having this new indication formally authorised by a regulatory authority.
As part of the pilot, the EMA and national medicines agencies will provide regulatory support and primarily scientific advice, to help stakeholders to generate data robust enough to support a future application by a pharmaceutical company.
Candidate medicines for the pilot will be required to contain a well-established active substance, and target an indication in an area where important public health benefits are likely to be achieved.
The pilot will focus on conditions for which no or few medicines are currently authorised or are associated with high morbidity or mortality—or both—despite available medicines.
Eligible academia sponsors developing orphan medicines will benefit from a fee waiver. Additional fee waivers will be granted to selected applications, taking into account the extent of the expected public health benefits and the strength of the evidence to substantiate the proposal.
This article originally appeared on Univadis, part of the Medscape Professional Network.
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