International Journal of Science, Engineering and TechnologyAuthors: Aman Ratandeep Harwani, Ishan Patel
Abstract: The globalization of pharmaceutical markets has necessitated greater alignment among national regulatory authorities to ensure patient safety, drug efficacy, and timely access to therapeutics[1][2][3]. This review critically examines the similarities and differences in drug approval pathways across three major regulatory systems—the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO) of India. Each of these agencies follows distinct procedural frameworks for Investigational New Drug (IND) applications, clinical trial oversight, and marketing authorization[1][2][3]. While the USFDA and EMA emphasize accelerated pathways, orphan designations, and structured benefit-risk assessments[1][4], the CDSCO has made significant strides toward harmonization through the New Drugs and Clinical Trials Rules (2019) and adoption of the Common Technical Document (CTD) format[5][6]. Despite these advances, considerable divergence persists in submission timelines, review transparency, and post-marketing surveillance mechanisms. Quantitative analysis reveals that drugs approved by the CDSCO face an average lag of 43.2 months compared to the USFDA, 25.6 months versus the EMA, and 30.3 months against the PMDA[7]. However, recent 2024 clinical trial waiver expansions under Rule 101 are progressively reducing this gap[8]. The review further highlights ongoing convergence efforts led by the International Council for Harmonisation (ICH) through harmonized guidelines such as E6(R3), Q8-Q10, and mutual recognition arrangements[9][10]. Overall, harmonization of regulatory standards can minimize duplication, enhance global collaboration, and expedite patient access to essential medicines..
DOI: http://doi.org/10.5281/zenodo.18136767
