Brazilian Journal of Pharmaceutical Sciences
On-line version ISSN 2175-9790
CARVALHO, Ana Cecília Bezerra et al. Regulation of herbal medicines in Brazil: advances and perspectives. Braz. J. Pharm. Sci. [online]. 2011, vol.47, n.3, pp.467-473. ISSN 2175-9790. http://dx.doi.org/10.1590/S1984-82502011000300004.
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.
Keywords : Herbal medicines [Regulation]; Herbal medicines [Quality control]; Medicines [Good Manufacture Practices]; Pharmaceutical industry.