Regulation of herbal medicines in Brazil

Abstract

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.

Materials and methods: The national and international legislation on herbal medicines was revised to prepare new Brazilian standards. This new legislation is discussed.

Results: This new proposed regulation separates herbal into two categories: herbal medicines (HM) and traditional herbal product (THP). The safety and efficacy of HM must be proven by clinical data. ANVISA recognizes some plants as safe and effective; therefore, the registration of these species can be simplified. ANVISA also recognizes the monographs of the European community as simplified registrations. THP can prove their safety and effectiveness by tradition of use or following a simplified registration.

Conclusion: Brazil has been altering their legal standards for herbal medicines, based on harmonization with internationally practiced requirements and the characteristics of the Brazilian market, facilitating the safe access and rational use of medicinal plants and herbal products to Brazilian population.

Keywords: Brazil; Herbal medicines; Regulation; Traditional herbal products.