Abstract
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.
Highlights
Within the context of the supply chain of medicinal plants and herbal medicines, the Brazilian health legislation, which provides for herbal medicines registration, has recently been updated and published as Resolução de Diretoria Colegiada (RDC) 14/10, in line with the scientific and technological developments enabling the expansion of the population’s access to these medicines (Brasil, 2010b)
Only in 2006 did the Brazilian Government define policies, considered a milestone for the industry of medicinal plants and herbal medicines at the time, in the form of the Política Nacional de Práticas Integrativas e Complementares (PNPIC) (Ministerial GM/MS 971/06) and Política Nacional de Plantas Medicinais e Fitoterápicos (PNPMF) (Decree 5,813/06). These policies contain among their guidelines, fostering of research on medicinal plants and development of herbal medicines of quality, safety and efficacy standards that must be made available to the population while prioritizing the protection of biodiversity and promoting greater access to safe and effective treatments (Brasil, 2006a,b)
It was published in order to improve the form and content of the labels of all registered medicinal products marketed in Brazil
Summary
Within the context of the supply chain of medicinal plants and herbal medicines, the Brazilian health legislation, which provides for herbal medicines registration, has recently been updated and published as RDC 14/10, in line with the scientific and technological developments enabling the expansion of the population’s access to these medicines (Brasil, 2010b). Only in 2006 did the Brazilian Government define policies, considered a milestone for the industry of medicinal plants and herbal medicines at the time, in the form of the PNPIC (Ministerial GM/MS 971/06) and PNPMF (Decree 5,813/06) These policies contain among their guidelines, fostering of research on medicinal plants and development of herbal medicines of quality, safety and efficacy standards that must be made available to the population while prioritizing the protection of biodiversity and promoting greater access to safe and effective treatments (Brasil, 2006a,b). The Brazilian Health Surveillance System, coordinated by ANVISA, is responsible for assessing the herbal medicine industry in Brazil, while State and Municipal assessments are performed by their respective local governments These two policies govern surveillance of marketing, dispensing, handling and distribution of raw materials of plant origin, as well as the registration and supervision of herbal medicine production (Brasil, 1999). It is important that researchers look to health legislation and take a more focused ap proach on the productive sector in order to generate more information on the Brazilian plant species available, and to ensure more herbal medicines products are registered (Toledo et al, 2003)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
