The European Repurposing Pilot Project

Le résumé fourni par la source

The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) repurposing pilot project started from discussions on a proposal for a medicines repurposing framework within the European Commission (European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients, STAMP). Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the STAMP a multistakeholder Repurposing Observatory Group (RepOG) was created to oversee the implementation of the pilot project. The RepOG is composed of representatives of regulatory authorities, the European Commission, champion interest groups, industry and HTA bodies. The RepOG is led by the Spanish Agency of Medicines and Medical Devices (AEMPS) together with the EMA. In addition, there is a regulators subgroup involving representatives of EMA and the NCAs to facilitate and monitor the pilot progress. The overall aim of the repurposing pilot project is to support not-for-profit organisations and academia to gather or generate enough evidence to support repurposing of an already authorised medicine for a new indication. The indication should contribute to important public health needs. The project was opened to champions (generally seen as not-for-profit organisations). A champion can be, for example, an entity or a person from an academic unit/charity or patient organisations/learned society/research funder or payer. The pilot was launched in October 2021, and further to the call for candidate project submission, the eligible projects are currently under the Scientific Advice phase. A report on the advances/results on the pilot will be elaborated in due time.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.