This article aims to offer a comparative analysis of regulations guiding vaccine approval processes in the United States, European Union, India, Australia, and South Sudan, particularly to understand the regulatory challenges that South Sudan faces and highlight possible solutions. The data sources include official regulatory databases of the five countries and articles from PubMed, Scopus, and Google Scholar. Inclusion criteria include articles published in English from the year 2014-2024 that encompass regulatory procedures for countries in scope. The paper starts with a comparison of basic regulatory frameworks for vaccine approval in the US, European Union, India, and Australia. The analysis then proceeds to explore the regulatory context of South Sudan where major challenges arise from inadequate infrastructure, lack of expertise, and resource limitations. These obstacles hinder the fast approval and distribution of vaccines and affect public health. To address these deficiencies, the article proposes recommendations, regulatory harmonization, international collaboration, and the adoption of streamlined approval pathways. The comparative analysis underscores the critical disparities in vaccine regulatory capacity across nations. While developed regions possess well-established systems, South Sudan faces substantial hurdles that necessitate targeted interventions. The proposed solutions aim to strengthen South Sudan's regulatory framework, ensuring timely access to safe and effective vaccines..
Keywords: Regulations; regulatory; approval; vaccines; biologics
How to cite this article:Agarwal C, Pai A, B V, Bhat BB, A Comparative Study Of The Regulatory Approval Process Of Vaccines In The United States, European Union, India, Australia, And South Sudan .Int J Drug Deliv Technol. 2026;16(1s): 932-948; DOI: 10.25258/ijddt.16. 932-948