Regulatory science of natural products.

Foods and pharmaceuticals play key roles in public health and welfare and ensuring that these products meet their quality assurance standards is a top priority in health and medical care. Quality assurance of natural products is essential in pharmaceutical sciences because the outset of a medicine is a natural, crude drug. Regulatory science underpins scientific regulations and is closely related to the quality assurance of foods and pharmaceuticals to ensure their safety and efficacy. During my time at the National Institute of Health Sciences, Japan, from 1986 to present, the regulatory science of natural products has been my main research focus. This review discusses 24 studies related to the regulatory science of natural food additives, 26 related to foods, 23 related to borderline products, 16 related to illicit psychotropic mushrooms, plants, and agents, and 57 related to herbal medicines. In later sections, the regulatory science for ethical Kampo products with new dosage forms and herbal medicines that use Kampo extracts as active pharmaceutical ingredients are discussed. My experience from the early twenty-first century in research projects on the bioequivalence of Kampo products and the development of ephedrine alkaloid-free Ephedra Herb extract demonstrate that regulatory science is crucial for developing new drugs.