REGULATORY CHALLENGES IN THE PHARMACEUTICAL INDUSTRY: A GLOBAL PERSPECTIVE

Abstract

The pharmaceutical industry operates under stringent regulatory frameworks to ensure drug safety, efficacy, and quality. However, regulatory challenges persist due to evolving scientific advancements, global market complexities, and differences in regulatory policies across regions. This paper explores the key regulatory hurdles faced by the pharmaceutical industry globally, including compliance with diverse regulatory bodies, delays in drug approvals, evolving guidelines for clinical trials, and the impact of emerging technologies. It also examines potential solutions to harmonize regulations and improve efficiency in pharmaceutical governance. Keywords: Pharmaceutical Industry, Regulatory Challenges, Drug Approval, Global Regulations, Compliance, Clinical Trials, Emerging Technologies.