Medicines repurposing project launched in Europe

Generics and biosimilars Initiative

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Medicines repurposing project launched in Europe

Genéricos/General | Posted 21/01/2022 0 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.

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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LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos en América Latina Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Diferencias en estudios clínicos y farmacovigilancia de medicamentos biológicos en América Latina Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

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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