Abstract

REGULATORY ASPECTS OF PHARMACOGENOMICS IN CLINICAL DRUG DEVELOPMENT

Gokaraju Meghana Kumari*, M. V. Nagabhushanam and Adilakshmi C. H.

ABSTRACT

Pharmacogenomics (PGx) plays a pivotal role in advancing personalized medicine by studying genetic variations that influence drug response, safety, and efficacy. Its integration into clinical drug development has led to significant regulatory considerations aimed at ensuring the ethical, safe, and effective use of genetic information. Regulatory agencies, including the FDA, EMA, and PMDA, have established guidelines for the inclusion of PGx data in drug development, covering aspects such as biomarker identification, companion diagnostics, clinical trial design, and labeling requirements. These frameworks emphasize patient protection through informed consent, data privacy, and rigorous validation of genomic biomarkers. The co-development of drugs and diagnostic tools ensures precise patient stratification and enhances therapeutic outcomes. However, challenges such as global regulatory harmonization, ethical dilemmas, and resource constraints persist. Despite these challenges, theregulatory oversight of pharmacogenomics facilitates the development of tailored treatments, improves drug safety, and supports the transition from a "one-size-fits-all" approach to precision medicine. This abstract highlights the critical regulatory aspects underpinning the successful integration of pharmacogenomics into clinical drug development and its transformative impact on modern healthcare.

Keywords: Pharmacogenomics (PGx), Clinical Drug Development Process, Regulatory Aspects, FDA, EMA, and PMDA.