The regulatory status of herbal medicines in Brazil: A comparison between the legislation and the pharmaceutical market (1995–2015)
DOI:
https://doi.org/10.22239/2317-269X.00806Keywords:
Drug Laws, Government Regulation, Herbal Medicine, Medicinal Plants, Pharmaceutical MarketAbstract
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.Downloads
Downloads
Published
Issue
Section
License
Copyright (c) 2016 Health Surveillance under Debate: Society, Science & Technology (Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnología) – “Visa em Debate”
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.
