International Journal Of Drug Regulatory Affairs
  • Year: 2024
  • Volume: 12
  • Issue: 2

A review on various aspects of regulatory affairs

  • Author:
  • Swaranjali Pore, Jeevan Deshmukh, Shivani Biskite, Snehal Jadhav, Akshata Moharekar, Ankita Gurav
  • Total Page Count: 9
  • Page Number: 18 to 26

Adarsh College of Pharmacy, Shivaji University, Kolhapur, Near MIDC Khambale, Vita, 415311, Maharashtra, India

Online published on 25 June, 2025.

Abstract

In order to guarantee the efficacy, safety, and calibre of medications, medical equipment, and other healthcare supplies, Regulatory Affairs is essential. Anticipating future trends and difficulties in Regulatory Affairs is crucial as the healthcare sector changes due to technological breakthroughs, globalization, and new regulatory paradigms. This abstract examines the consequences of developing fields for regulatory frameworks, including gene treatments, digital health, artificial intelligence, and personalized medicine. It also covers the increased significance of real-world evidence, patient-centric approaches, and international harmonization in regulatory decision-making. In addition, it looks at the difficulties presented by supply chain interruptions, cybersecurity risks, and regulatory divergence in a world that is changing quickly. Stakeholders may effectively navigate the complicated regulatory landscape of the future by embracing innovation, collaboration, and adaptive regulatory methods facilitate the timely delivery of safe and effective healthcare products to patients worldwide.

Keywords

Efficacy, Regulatory Affairs, Globalization, Artificial Intelligence, Stakeholder, Innovation