Botanical Drug Development : How Natural Health Products Can Become Drugs

Abstract

Botanical drugs (BDs) represent an untapped global opportunity in which natural health products (NHPs) are developed and marketed as drugs. These products are a potentially disruptive technology that could help fill drying pharmaceutical developmental pipelines while simultaneously addressing the demographic shift of the rapidly ageing population that is seeking products perceived as effective, naturally derived and safe. This article provides an overview of the BD-development process, highlighting the differences between BDs and single chemical entities. Lastly, the business process by which these products can be simultaneously developed across multiple regulatory environments is described, along with suggestions of how the pharmaceutical industry can work with the companies currently developing NHPs. Ultimately, successful US Food and Drug Administration (FDA) approvals and successful marketing of BDs will benefit the pharmaceutical industry, the NHP industry and patients alike.

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