Drug Repurposing for Inclusion of COVID-19-Related Indication: Field Study of the European Medicines Agency's Response to the Pandemic.

As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency's resources and required constant adaptation and mobilization of different regulatory processes. In this situation, drug repurposing appeared as a promising potential approach in quickly emerging health crises due to its main advantage of reducing the time and cost for addition of new indications since it uses products proven to be of high quality, safe, and effective. We performed an analysis of European Public Assessment Reports for medicinal products authorized for the SARS-CoV-2 infection by the European Medicines Agency, showing a total of eight products with this indication, three (37.5%) of which used repurposing as a mechanism for development (remdesivir, tocilizumab, and anakinra). The application of this mechanism by these medicines highlights the importance of the life cycle stage at which repositioning is undertaken, which resulted in different volumes of data submitted in the respective European Public Assessment Reports. The participation of organizations other than the marketing authorization holder in key stages in the drug development process of repurposed products was once again confirmed, which emphasizes the need to regulate this interaction.