Repurposing of Medicines in the EU: Launch of a Pilot Framework
Status PubMed-not-MEDLINE Language English Country Switzerland Media electronic-ecollection
Document type Journal Article
PubMed
35083258
PubMed Central
PMC8784735
DOI
10.3389/fmed.2021.817663
Knihovny.cz E-resources
- Keywords
- COVID-19, European Union, off patent authorised medicines, patient access, pilot launch, repurposing, repurposing observatory group,
- Publication type
- Journal Article MeSH
Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the frontline by proving the usefulness of this practise in favour of patients for an early access to treatment. Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) a virtual Repurposing Observatory Group (RepOG) was set up in 2019 to define and test the practical aspects of a pilot project thought to provide support to "not-for-profit" stakeholders generating or gathering data for a new therapeutic use for an authorised medicine. The group's initial plan was impacted by the outbreak of the SARS-CoV-2 pandemic and the launch of the pilot needed to be postponed. This article describes the progress and the activities conducted by the group during this past and yet extraordinary 2020-2021 to keep the project alive and explores on the background of this topic together with the obvious opportunities this health crisis has brought up in terms of repurposing of medicines.
Association Internationale de la Mutualité Pharmaceutical Working Group Brussels Belgium
Director of the Marketing Authorisation Section State Institute for Drug Control Prague Czechia
European Commission Directorate General for Health and Food Safety Brussels Belgium
European Commission Directorate General Research and Innovation Brussels Belgium
European Confederation of Pharmaceutical Entrepreneurs Brussels Belgium
European Federation of Pharmaceutical Industries and Associations Brussels Belgium
Federal Agency of Medicines and Health Products Brussels Belgium
Medicines for Europe Brussels Belgium
Regulatory Affairs Office Human Medicines Division European Medicines Agency Amsterdam Netherlands
Swedish Medical Products Agency Uppsala Sweden
Treatment Information and Access European Organisation for Rare Diseases Paris France
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