Drug repurposing is often promoted as a faster, lower-risk alternative to de novo discovery, yet substantial barriers continue to limit successful implementation. We performed a scoping review of articles included in PubMed and ScienceDirect with the aim to identify and categorize challenges and analyze the intersections between them. Our review included 73 articles which revealed scientific, clinical, regulatory, economic, and implementation barriers, with the principal being the clinical translation of generated candidates. Scientific challenges include the necessity for new Phase II/III trials to validate efficacy, safety, and optimal dosing in new therapeutic contexts. Across disease areas, domain-specific barriers include subgroup-dependent responses in oncology, resistance and penetration challenges in anti-infectives, and data scarcity in rare diseases. Computational and AI-assisted approaches face fragmented data, model robustness, and insufficient validation. In addition, off-patent drugs face evidence requirements as rigorous as those for de novo entities, yet lack the market exclusivity incentives required to attract private investment. Additionally, an “institutional bottleneck” hinders academic researchers from bringing findings “on-label” due to a lack of regulatory infrastructure and collaborative frameworks. We conclude that drug repurposing requires a distinct translational paradigm involving multi-stakeholder collaboration and early regulatory engagement to bridge the gap between laboratory discovery and patient access.

Drug repurposing is a modern and successful mechanism for discovering new therapeutic indications for authorised medicinal products. There is an absence of a clear definition of the term “drug repurposing” or its synonyms in regulatory frameworks, which clearly shows the need for inclusion and definition of the process. The main regulatory documents show a greater absolute number of repurposing options for European Medicines Agency (EMA) (5) versus Food and Drug Administration (FDA) (4) and the need for harmonisation because of different authorisation procedures and their benefits. While the EU Agency focusses on regulating and improving the interaction between pharmaceutical companies, academia, and non-profit organisations, the U.S. drug regulator directs the generation of candidates for repurposing using digital technologies.

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.

Purpose: Digital transformation, as a modern phenomenon, encompasses almost all areas of life, including military medicine and pharmacy. This study aims at reviewing the historical development and key aspects and challenges in the modern process of applying digitalization technologies in the structures of the armed forces. Material/Methods: Review of the Google Scholar database and websites of governmental institutions was performed to identify the most prominent areas where digital transformation is utilized. Results: We have identified that the use of such technologies can take place in the theatre of war itself, mainly through telemedicine, contributing to reduced costs, enhancing medical evacuations and lowering mortality. On the other hand, the other main implementation is in peacetime where trends are aimed at providing more efficient health and pharmaceutical care to servicemembers and veterans, as well as conducting in-depth analyses of military medical supply and crisis response preparedness. While an appropriate population due to its centralized management and hierarchy, there are several challenges to digital technology implementation in the military. These include administrative hurdles, policies, and the need for specific digital products that meet stringent cybersecurity and secrecy requirements. Conclusions: Despite military medicine and pharmacy being pioneers in implementing digital technologies starting in the 60s, there are signs of delayed digital transformation relative to the civilian population, need to address challenges more effectively, and a need of military-customized digital solutions.

Real-world data catalogs established by the Heads of Medicines Agencies and the European Medicines Agency (HMA–EMA RWD catalogues) represent a centralized digital approach for broad access to reliable data to ensure patient safety. In this study, RWD catalog analysis was conducted in order to identify best practices and challenges, focusing on finalized non-interventional studies (NISs) with a scope specified as ‘safety’. The results (n = 240) show a predominance of studies required by a pharmaceutical regulator (56.6%) as well as the importance of NIS in pharmacovigilance via inclusion in risk management plans (RMPs) (52%) and broad use of NIS in risk minimization measure (RMM) evaluation. However, the lack of a unified regulatory framework, insufficient published data, and the recognized need for digital tool implementation create the necessity for improvement within the European Union (EU) pharmaceutical legislation.