The regulatory status of herbal medicines in Brazil: A comparison between the legislation and the pharmaceutical market (1995–2015)

• Autor(a) principal: Oliveira, Danilo Ribeiro de
• Data de Publicação: 2016
• Outros Autores: Oliveira, Ana Claudia Dias de, Marques, Luis Carlos
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/806
• topic: Legislação de Medicamentos; Regulamentação Governamental; Fitoterápicos; Plantas Medicinais; Mercado Farmacêutico; Drug Laws; Government Regulation; Herbal Medicine; Medicinal Plants; Pharmaceutical Market

Until the mid-1990s there was no specific regulations for herbal medicines in Brazil, leading to the disorderly growth of the pharmaceutical industry that occupied the drug production within a category considered hitherto low risk. However, this scenario has changed drastically in the last 20 years, due to the publication of 5 regulatory frameworks that regulated the herbal registration in safety aspects, efficacy and quality, and significantly improved the product profile on the market. Over the years, the rules expanded the number of species for simplified registration improving the ability to obtain the marketing authorization based on the tradition of use. But in a contradictory way, these rules maintained, and even increased, accuracy in quality control, which has become a complicating factor, along with the rules of good manufacturing practices for herbal medicines registration in general, including those originating from native species and herbal compounds. Therefore, the development of regulatory standards resulted in a maturing of the Brazilian herbal medicine market, but some negative aspects are worth mentioning, like the small number of native species registered as herbal medicines. In this sense, it is expected a better alignment of government and the productive sector, considering the government programs geared to medicinal plants and herbal medicines and the new Biodiversity Law, so Brazil can advance the availability of herbal medicines with quality, efficacy and safety.