Regulating nanomedicines: challenges, opportunities, and the path forward.

Abstract

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 measures associated with the nanomedicines. This review highlights the existing regulatory gaps by analyzing the clinical applications of nanomedicine, discussing the significance of regulatory frameworks. The barriers to the regulatory systems of various countries are compared to identify the multifaceted challenges associated with ensuring the safety and efficacy of nanomedicine interventions. The lack of consensus not only impedes the research and development (R&D) efforts in nanoparticle-based therapies but also affects the future adoption of nanomedicines. There is an urgent need to establish and implement a coherent and globally synchronized regulatory framework to facilitate the innovation and advancements of nanomedicines.