The use of medicinal plants in Brazil is widespread and is supported by public policies; it has the objective of providing the population with safe and effective herbal medicines of adequate quality. An action in these policies is to develop medicinal plant monographs to gather published information and decide which medicinal plants should be financed by the Brazilian government and distributed by the public health system. Currently, the monographs published worldwide do not present unified information regarding medicinal plants, and generally, they do not cover enough requirements for herbal medicine registration. The aim of this study is to develop a monograph model with standardized information not only about botany, agronomy, quality control, safety, and efficacy but also about relating regulatory aspects that support herbal medicine regulation. The development of standardized monographs favors the fast authorization and distribution of herbal medicines in the public system. The model also points out the lacking studies that should be carried out to supplement the necessary regulatory information of medicinal plants.
Monograph; Regulation; Medicinal plant; Herbal medicine