Regulatory landscapes for approval of naturally-derived complex mixture drugs

The chapter contains brief surveys of current approaches used in countries around the world in the regulation of naturally-derived complex drugs. There is a marked diversity in the scientific and regulatory approaches in different regions, depending on history, the recognition and integration of traditional medicine systems, the evolution of regulatory bodies, and government regulatory philosophies. In the USA, there is a sharp regulatory distinction between drug and non-drug entities, based primarily on whether or the intended use is for treatment, prevention, or mitigation of disease states; for example, an herbal preparation may be registered as a botanical drug conforming to drug laws and guidelines, or it may be marketed essentially in the form of a dietary supplement. However, in many countries such as Europe, there is a particular regulatory class "herbal medicinal products" with some specific regulations within the framework for medicinal products. Countries such as Australia and Canada have developed a more comprehensive and tailored approach developing regulatory frameworks working off the therapeutic good/drug model that captures most herbal and traditional medicines on the market. In Asia, the regulatory approaches provide a special framework for the traditional systems of medicine, such as Ayurveda or traditional Chinese medicine (TCM). Interestingly in India, there is the development of hybrid categories, wherein some products from traditional medicine can be modified or specially formulated and marketed. In these subchapters, the heterogeneous environments, histories, and regulatory intents are captured and reflected for the USA, Europe, Canada, Australia, China, India, and World Health Organization and National Institute for Biological Standards and Control. However, these subchapters are instructive for background and context in the book's treatment of the regulation of naturally-derived complex mixture drugs in this age of globalization.