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. AIM OF THE STUDY: to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. MATERIALS AND METHODS: a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. RESULTS: There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. CONCLUSIONS: There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil.

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. 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.

Regulation of herbal medicines in Brazil: advances and perspectives / Regulamentação de medicamentos fitoterápicos no Brasil: avanços e perspectivas

The National Policy of Integrative and Complementary Practices (PNPIC) in the Brazilian Unified Health System (SUS), and The National Policy of Medicinal Plants and Herbal Medicines (PNPMF) were launched in 2006. Based on these, the Brazilian Health Surveillance Agency (ANVISA) re-edited rules related to herbal medicines such as the Guideline to herbal medicine registration (RDC 14/10), the Good Manufacture Practices Guideline (RDC 17/10) and the List of references to assess the safety and efficacy of herbal medicines (IN 05/10). The requisites to prove herbal medicine's safety and efficacy were updated. Therefore, this review aims at presenting and commenting these new rules.

Em 2006, dois importantes documentos foram publicados no Brasil: a Política Nacional de Práticas Integrativas e Complementares (PNPIC) no Sistema Único de Saúde (SUS) e a Política Nacional de Plantas Medicinais e Fitoterápicos (PNPMF) à luz das quais a ANVISA avaliou as normas para o setor. Como produto dessa avaliação, foram republicadas as normas para registro de medicamentos fitoterápicos, por meio da Resolução de Diretoria Colegiada (RDC) 14/10, as Boas Práticas de Fabricação e Controle de medicamentos na indústria farmacêutica, RDC 17/10, e a lista de referências para comprovação da segurança e eficácia de medicamentos fitoterápicos, na forma da Instrução Normativa (IN) 05/10. Em relação às normas anteriormente vigentes, foram atualizados os requisitos para comprovação da segurança e eficácia destes medicamentos e sugeridas alternativas ao controle da qualidade de cada etapa de produção. Dessa forma, essa revisão tem por objetivo apresentar tais normas destacando suas características principais.