Regulating nanomedicines: challenges, opportunities, and the path forward

Over the past decade, nanomedicines have witnessed significant advancements, with various nanocarriers being introduced into clinical practice. Despite this progress, the absence of a well-defined regulatory framework presents major challenges for stakeholders in the pharmaceutical and healthcare industries. Challenges in biocompatibility, nanotoxicology, and regulatory oversight limit the clinical translation of nanomedicines. This review discusses the key challenges and emphasizes on the lack of clear and effective regulations in nanotechnology, which creates obstacles for manufacturers while also leaving legislators, medical practitioners, and the general public unable to properly assess the risk and safety…