Drug Repurposing and Its Application in the Context of the Current Drug Regulatory Framework

• Drug repurposing offers a cost-effective and time-efficient alternative to traditional drug development, leveraging existing safety data. • Regulatory pathways such as the 505(b)(2) application and similar frameworks in other regions are critical enablers for drug repurposing. • Computational methods and real-world data are increasingly used to identify repurposing candidates and support regulatory submissions. • Harmonization of regulatory standards and data sharing can accelerate the translation of repurposing opportunities into clinical practice.