Medicines repurposing project launched in Europe

Generics/General | Posted 21/01/2022 post-comment0 Post your comment

In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.

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This European drug repurposing project comes as a follow-up to discussions held by the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP), on medicines repurposing and the development of a European medicines repurposing framework [1].

The pilot project aims to support not-for-profit organizations and academia in providing adequate evidence on the use of established medicines in new indications. This initiative hopes to make new treatment options available to patients without the need to develop new products.

Together, EMA and national medicines agencies will provide regulatory support, scientific advice, and offer fee waivers and other support to organizations exploring new uses for existing drug products. They will also connect these organizations with pharmaceutical partners to seek marketing authorization.

It has been outlined that candidate medicines for the pilot should contain a well-established active substance and be an authorized medicine out of data exclusivity and market protection periods. The candidate must also target an indication in a condition distinct from the currently authorized indication(s) and one that is in an area where important public health benefits are achievable.

The pilot will focus on conditions for which no or few medicines are currently authorized or conditions which currently have an associated high morbidity and/or mortality.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Europe calls for more drugs repurposing [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 21]. Available from: www.gabionline.net/generics/general/Europe-calls-for-more-drugs-repurposing

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