Regulatory processes involved in clinical trials and intellectual property rights around vaccine development

Nimeet Desai, Shreya Pande, Amol D. Gholap, Dhwani Rana, Sagar Salave, Lalitkumar K. Vora

Research output: Chapter in Book/Report/Conference proceedingChapter


This chapter explores the critical intersection of regulatory processes and intellectual property rights (IPR) within the context of vaccine development. With the ongoing global focus on public health and the urgent need for effective vaccines, understanding the intricate regulatory frameworks and IPR landscape becomes vital for stakeholders in the pharmaceutical and biotechnology industries. The chapter begins by providing a comprehensive overview of the regulatory processes governing clinical trials, delving into the various stages, including preclinical testing, investigational new drug applications, and the distinct phases of human clinical trials. The ethical considerations inherent in clinical research and the importance of adherence to regulatory guidelines are emphasized. Moreover, the chapter examines the roles and responsibilities of regulatory bodies involved, such as the Food and Drug Administration in the United States, the European Medicines Agency in Europe, and other regional authorities. Furthermore, this chapter explores the intricate relationship between vaccine development and IPR. It examines the impact of IPR on vaccine accessibility, including potential monopolies, high prices, and implications for global health equity. The protection of intellectual property rights, such as patents, trademarks, and licensing agreements, is discussed in detail. Strategies for balancing IPR protection with the need for affordable and accessible vaccines are explored, including technology transfer, compulsory licensing, and patent pooling. The global regulatory frameworks governing clinical trials are also addressed, focusing on international guidelines, harmonization efforts, and regional challenges. The chapter examines regulatory approval processes, postmarketing surveillance, and expedited pathways for vaccine development, including emergency use authorization. Lastly, the chapter delves into the practical aspects of clinical trial management, encompassing site selection, regulatory submissions, monitoring, safety reporting, data management, and trial completion. This chapter provides a comprehensive analysis of the regulatory processes involved in clinical trials and their interaction with IPR in the context of vaccine development. It serves as a valuable resource for researchers, policymakers, and industry professionals seeking a deeper understanding of the complex dynamics surrounding vaccine regulation and intellectual property.

Original languageEnglish
Title of host publicationAdvanced vaccination technologies for infectious and chronic diseases: a guide to vaccinology
EditorsVivek P. Chavda, Lalitkumar K. Vora, Vasso Apostolopoulos
PublisherElsevier Ltd
ISBN (Electronic)9780443185649
Publication statusPublished - 29 Mar 2024

Publication series

NameDevelopments in Immunology


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