Regulatory Perspectives of Botanical Drug Products in Top Pharmaceutical Markets

Abstract

Botanical drug products are becoming increasingly popular in the pharmaceutical market. This has sparked the creation of legislative documents by government agencies that regulate developing and marketing botanical drugs. Agencies like the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union make sure that all botanical drug products added to the pharmaceutical market have therapeutic benefits that outweigh their adverse effects. Though there are challenges in following the regulations, like guaranteeing constant potency and purity with each batch, there are also loopholes, like marketing botanical drug products as dietary supplements instead of over-the-counter or prescription medications. This chapter discusses the regulations for developing botanical drugs in the United States, European Union (EU), Canada, Japan, Australia, Brazil, China, India, and the Association of Southeast Asian Nations (ASEAN), and also touches on how these regulations globally affect market positioning and drug development.