Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products.

Despite the vast global botanical diversity, the pharmaceutical development of herbal medicinal products (HMPs) remains underexploited. Of over 370,000 described plant species, only a few hundred are utilized in HMPs. Most of these have originated from traditional use, and only a minority come from megadiverse countries.

The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines.

Ethnopharmacological Relevance: the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge.

Regulation of herbal medicines in Brazil.

Ethnopharmacological Relevance: Rich Brazilian biodiversity is accompanied by a long acceptance of medicinal plants and traditional knowledge by the Brazilian population. To improve the regulatory framework for herbal medicines in Brazil, ANVISA recently revised its legislations. The aim of this study is to discuss the new Brazilian standards for herbal medicines regulation.