Address for Correspondence: Mrs. V R Teja Sruthi Pagadala, Mail: tejam.pharmacy@gmail.com How to Cite this Article: Mrs. V R Teja Sruthi Pagadala, ONE MEDICINE, MANY RULES: GLOBAL HARMONIZATION AND REGULATORY FRAGMENTATION IN DRUG APPROVALS, World J Pharm

Abstract

The globalization of pharmaceutical markets has intensified the need for a unified regulatory approach to facilitate timely access to safe, effective, and affordable generic medicines. Despite advances in international regulatory harmonization, significant fragmentation persists among global drug approval systems, creating challenges for pharmaceutical development, post-approval management, and lifecycle optimization. This research critically examines the current regulatory landscape governing generic drug approvals across major global regions, highlighting both convergence and divergence in regulatory expectations. The study is structured into five analytical chapters covering regulatory frameworks in ASEAN countries, post-approval change management practices in the United States and European Union, regulatory submission requirements in Australia, and comparative bridging strategies across Australia, Canada, Europe, Russia, and ASEAN nations. Special emphasis is placed on post-approval variation procedures, regulatory timelines, documentation requirements, and risk-based classification systems adopted by different authorities. Industry-based case studies are incorporated to evaluate practical challenges and strategic solutions for global product development. Findings indicate that while harmonization initiatives such as ICH guidelines have improved regulatory consistency, region-specific procedural requirements, data expectations, and approval pathways continue to hinder the development of a single globally acceptable drug product. The research underscores the importance of proactive regulatory planning, reliance-based submissions, and strategic bridging approaches to minimize duplication, reduce development costs, and accelerate global market access. This study contributes to regulatory science by proposing integrated regulatory strategies aimed at balancing global harmonization with regional regulatory autonomy, ultimately supporting efficient generic drug development and improved patient access worldwide