The Great Drug Regulation Divide: How Resource Imbalance Is Strangling Global Health Equity

Authors

  • Wenhan Jiao China Pharmaceutical University, Nanjing, China
  • Wanyu Zhang China Pharmaceutical University, Nanjing, China
  • Shanshan Kang China Pharmaceutical University, Nanjing, China

Abstract

This study investigates the global disparity in the allocation of pharmaceutical regulatory resources, focusing on the significant gap between high-income and low-income countries in terms of regulatory capacity, drug quality, safety, and accessibility. It highlights how differences in resources directly impact the ability of low-income countries to ensure the safety and availability of medicines, with high-income countries benefiting from more robust regulatory systems. The research utilizes a mixed-methods approach, combining quantitative data analysis of regulatory budgets and staffing levels, alongside qualitative case studies of countries with data gaps, such as Haiti and Papua New Guinea. The study also includes a detailed case analysis of China—the world's second-largest pharmaceutical market—to explore how regulatory capacity differences manifest within a large, middle-to-high-income economy. The findings reveal that the regulatory divide not only constitutes a technical challenge but also represents a fundamental issue of global health equity and public health security. To address this divide, the study proposes solutions including strengthening international cooperation, enhancing regulatory capacity in low-income countries, and implementing digital tools to improve regulatory efficiency. The study concludes with policy recommendations and identifies future research avenues, emphasizing the need for standardized data collection, cross-country comparisons, and the development of regulatory frameworks that suit the unique needs of different countries.

Keywords: drug regulation, China, country income levels, pharmaceutical industry

Author Biographies

Wenhan Jiao, China Pharmaceutical University, Nanjing, China

Wenhan Jiao is an undergraduate student at the International Pharmaceutical Business School, China Pharmaceutical University, majoring in Pharmaceutical Administration. Her main areas of study focus on pharmaceutical regulation and global public health. During her studies, she has participated in introductory research related to the World Health Organization’s Global Benchmarking Tool (GBT) and has maintained an interest in the allocation of regulatory resources across countries. Through coursework, she has gradually developed skills in literature review, data organization, and basic analytical methods. In addition to academic learning, she actively participates in academic activities and volunteer services to broaden her perspective and gain practical experience. Looking ahead, she hopes to continue her studies and further explore the connections between pharmaceutical policy and public health.

Wanyu Zhang, China Pharmaceutical University, Nanjing, China

Wanyu Zhang is an undergraduate student majoring in International Trade at the International School of Pharmacy and Business, China Pharmaceutical University. Her academic interests center on pharmaceutical trade and global regulatory policy. Beyond classroom learning, she actively explores international pharmaceutical policy trends, such as comparing approval processes across countries and examining the distribution of pharmaceutical resources in cross-border trade. These explorations have provided her with a clearer understanding of the relationship between regulation and resource flows. In addition to academic studies, she values opportunities for international exchange, where she hopes to broaden her perspectives and gain practical experience. She is motivated to learn from diverse viewpoints, enhance her knowledge, and contribute actively in collaborative environments. Wanyu is enthusiastic about pursuing further studies and professional development in the pharmaceutical field.

Shanshan Kang, China Pharmaceutical University, Nanjing, China

Shanshan Kang is an Associate Professor of Economics and International Trade at the China Pharmaceutical University, School of International Pharmaceutical Business. With decades of experience in teaching Business English and cross-cultural communication, she has also served as a coordinator and instructor for the Global Partnership in Education. Prof. Kang's research focuses on treaties and conventions governing the international sale of goods, as well as regulations related to drug import and export. She has led and participated in multiple research projects, including a study on the regulatory system for market access of herbal medicines in the European Union. She has published several academic papers and acted as chief editor for a number of textbooks. Her recent publications include FDA Current Good Manufacturing Practice (CGMP) for Medical Products in the United States and Compilation of FDA Guidelines on Current Good Manufacturing Practice for Medical Products.

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Published

2026-02-24

Issue

Vol. 12 No. 1 (2026): Proceedings from the 9th Global Issues Conference

Section

Global Issues Conference Proceedings

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