Health and Safety Issues in Nanomaterials for Medical Applications: Regulatory Frameworks Governing Nanomedicine

Nanomedicine entails the application of nanoscale materials (generally 1 to 100 nm) that have transformed the healthcare sector by introducing novel methodologies for diagnostics, treatments, and targeted drug delivery. The primary health and biosafety issues in nanomedicine include cytotoxicity, tissue damage, immune system activation, accumulation and persistence in tissues, and lack of efficiency in translating promising preclinical results in laboratory settings in human trials. Other hurdles in the field of nanomedicine include large-scale manufacturing, maintaining quality and consistency, high production costs, lengthy and complicated approval processes and intellectual property issues related to development and commercialization. It underscores the need for regulatory frameworks in this domain to guarantee the safety of nanomedicines before clinical trials and market approval thereby providing legal certainty to the stakeholders. Although many authorized bodies have formulated regulations in this aspect for specific geographical areas, they vary globally and lack a formal, standardized regulation in the production, characterization and testing of nanomedicine and nanomaterial. This chapter emphasize the biosafety issues related to nanoparticles in biomedical applications and the necessity to evolve a uniform global regulatory framework in alignment with the rapidly evolving nanomedicines for the potential benefit of mankind.