A worldwide comparative-diagnostic study of medicinal natural products regulatory status

Abstract

Herbal products encompass a variety of preparations of plant origin that are the oldest form that humanity has been using to treat diseases, a practice that has grown enormously in the last decade. The aim of this study is to determine the natural medicinal products regulatory status of the main health authorities worldwide, to be used as a basis for improvement and optimization of legislation. Materials and Methods: A comparative study assessment of the natural medicinal products regulatory status in major health authorities in 2015, searching database of various government health agencies around the world, using keywords to find case law, regulations and laws on the subject and by information triangulation technique it was established the current regulatory situation. Results: It is well known that herbal products are not completely free of side effects, so is surprising that very few countries have a national policy to regulate and promote the safety and quality of medicinal plant materials. Depending on the country concerned, a herbal product could be defined as food, dietary supplement or herbal medicine. This disparity in the regulations that apply in different countries, influences access to products and international distribution plus it is not guaranteed that natural medicinal products meet the requirements of safety, efficacy and quality.