title: Regulation of herbal medicines in Brazil.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Agência Nacional de Vigilância Sanitária, Coordenação de Medicamentos Fitoterápicos e Dinamizados, SIA, Trecho 5, Área especial 57, Bloco A/B, 71.200-980 Brasília-DF, Brazil. Electronic address: cofid@anvisa.gov.br.
authors.forename: Ana Cecília Bezerra
authors.initials: AC
authors.lastname: Carvalho
authors.affiliation: Agência Nacional de Vigilância Sanitária, Coordenação de Medicamentos Fitoterápicos e Dinamizados, SIA, Trecho 5, Área especial 57, Bloco A/B, 71.200-980 Brasília-DF, Brazil. Electronic address: livia.ramalho@anvisa.gov.br.
authors.forename: Lívia Santos
authors.initials: LS
authors.lastname: Ramalho
authors.affiliation: Agência Nacional de Vigilância Sanitária, Coordenação de Medicamentos Fitoterápicos e Dinamizados, SIA, Trecho 5, Área especial 57, Bloco A/B, 71.200-980 Brasília-DF, Brazil. Electronic address: robelma.marques@anvisa.gov.br.
authors.forename: Robelma France de Oliveira
authors.initials: RF
authors.lastname: Marques
authors.affiliation: Agência Nacional de Vigilância Sanitária, Coordenação de Medicamentos Fitoterápicos e Dinamizados, SIA, Trecho 5, Área especial 57, Bloco A/B, 71.200-980 Brasília-DF, Brazil. Electronic address: joao.perfeito@anvisa.gov.br.
authors.forename: João Paulo Silvério
authors.initials: JP
authors.lastname: Perfeito
mesh_terms: D001938:Brazil; D006297:Health Services Accessibility; D006801:Humans; D007880:Legislation, Drug; D008519:Medicine, Traditional / Q000009:adverse effects / Q000592:standards*; D008517:Phytotherapy / Q000009:adverse effects / Q000592:standards*; D028321:Plant Preparations / Q000009:adverse effects / Q000592:standards*; D010946:Plants, Medicinal / Q000737:chemistry
chemical_list: D028321:Plant Preparations
keywords: Brazil; Herbal medicines; Regulation; Traditional herbal products