Efficacy, Safety, Quality Control, Marketing and Regulatory Guidelines for Herbal Medicines

Calixto, J. B. (2000). Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (Phytotherapeutic agents). Brazilian Journal of Medical and Biological Research, 33(2),179-189. Retrieved from: http://dx.doi.org/10.1590/S0100-879X2000000200004

This is a review about the safety, efficacy, quality control, marketing and regulation of botanical medicine, published in 2000 by the Brazilian Journal of Medical and Biological Research. The target audience would be regulatory, medical researchers, clinicians, and the public. The review is written by Professor Joao Batista Calixto a pharmacologist working at the Federal University of Santa Catarina, Brazil.  The article mentions the growing market in phyto-medicine which has attracted the interest of major pharmaceutical companies.  The study highlights the lack of access to related data on most plants and states that it is a fallacy to assume that herbal medicines are totally safe. This research is relevant because despite the scientific basis by significant publications of clinical studies for general practitioner’s prescriptions, still there is a lack of data to assess the efficacy and safety of most herbal medicine.  The review indicates that in many countries including the United States herbal medicine is sold as a dietary supplement, while in some other countries like the UK, there are drug regulations on some herbals, which require the safety and efficacy need to be proved in order to be registered. The study includes a compact review of policies in different countries following the suggestion for a global regulatory mechanism for herbal medicine regulation. In order to achieve this, a variety of steps are needed including well-controlled and randomized clinical trials to prove the efficacy and safety of herbal medicine; a process of regulation achieve global harmonization, and the requirement domesticate and genetic studies need.  This research has been done more than one and half decades ago, nevertheless, the issue of herbal medicine remains crucial, therefore, more up-to-date research is needed.