Abstract

DRUG REGULATORY AFFAIRS: A REVIEW ON CURRENT TRENDS AND FUTURE INSIGHTS

Revti Shah*, Sunita Ogale and Aakash Makwana

ABSTRACT

The review article explores recent developments and emerging themes shaping the regulatory landscape of the pharmaceutical industry. It examines key trends such as the increasing emphasis on real-world evidence, advancements in regulatory science and technology, globalization of regulatory frameworks, and evolving approaches to risk management and pharmacovigilance. Additionally, the article discusses the impact of digital health technologies, precision medicine, and biopharmaceutical innovations on regulatory requirements and approval pathways. By providing insights into these current trends, the review aims to inform stakeholders in the pharmaceutical sector, including regulators, industry professionals, and researchers, about the evolving regulatory environment and its implications for drug development, approval, and market access.

Keywords: Drug Regulatory Affairs, Regulatory Trends, Pharmaceutical Regulations, Compliance and Inspections, Regulatory Pathways, Globalization of Regulatory Frameworks