ABSTRACT

A revolutionary approach to medical care customizing healthcare to match patient-specific traits reliant on genetic variables, environmental extremes and lifestyle patterns is what precision medicine is all about. In this article, we explore the opinions of regulators concerning this area of specialization. More specifically, it looks at how the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have responded to Precision Medicine issues. Main aspects of precision medicine include genetic medicine, pharmacogenomics, biomarker-driven therapies and sophisticated diagnostics. The relevance of precision medicine is put across in terms of its impacts on treatment effectiveness, reducing adverse effects and contribution to medical knowledge. Some of the key regulatory challenges are: ensuring that genomic tests are analytically and clinically valid; addressing issues regarding data privacy; and developing suitable reimbursement models. The reviewed article addresses the regulatory frameworks of US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) in depth, delving into such initiatives as USFDA’s Precision MedicineInitiative and EMA’s Adaptation Pathways approach. The evolving regulatory landscape is captured in case studies of approved precision medicine products. Forecasts future trends in precision medicine regulation, such as incorporation of real-world evidence, regulation of artificial intelligence and machine learning, and addressing ethical issues in advanced therapies. In conclusion, the author argues that regulatory frameworks must continue to be refined at a pace with ever-growing technological innovations so as to ensure safety of patients yet also afford them equal access to the precise drug development. Keywords: Precision medicine, Genomics, Regulatory challenges, USFDA, EMA
Publication date: 01/03/2025

https://ijbpas.com/pdf/2025/March/MS_IJBPAS_2025_9720.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.3.9720