Regulatory intelligence-driven oversight of nanomedicines: gaps in US, EU, and India

A regulatory framework is required for the safe and successful clinical translation of nanomedicines. Accelerated global development: the nanomedicine market had a valuation of about USD ۲۴۱ billion in ۲۰۲۴, with projections suggesting it will grow at double-digit rates, driven by more than ۱,۰۰۰ active clinical trials across the globe. Several of these complex products include RNAi-based therapies and advanced liposomal formulations, all of which have received the green light from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the years past. However, there are notable geographical differences in the definitions, standards, and methods of testing for nanosimilarity. India's ۲۰۱۹ Guidelines for Evaluation of Nanopharmaceuticals marked the initial step, but Implementation and capacity are still limited. Significant regulatory gaps in immunogenicity testing, bioequivalence studies, uniform characterisation, and nano-specific pharmacovigilance leave producers and regulators in the dark. This review compares methods in the US, EU, and India using recently published clearance data, clinical trial findings, and policy papers. The role of regulatory intelligence (RI) is one of the primary concerns raised.RI a strategic tool to overcome fragmentation and enable foresight in the development of nanomedicine is the systematic monitoring of evolving regulations, authorizations, and safety reports.We conclude our offering by proposing recommendations to India on how to enhance post-market surveillance, develop capacity, set up specialized reference labs, and improve regulations. These recommendations for harmonized and evidence-driven oversight of nanomedicines make significant strides in articulating global lessons to national priorities.

کلیدواژه ها:

Nanomedicines ، Regulatory affairs ، FDA ، EMA ، CDSCO ، Regulatory intelligence.