Regulation of herbal medicines in Brazil: advances and perspectives

Authors

  • Ana Cecília Bezerra Carvalho University of Brasilia; Health Sciences Faculty
  • João Paulo Silvério Perfeito University of Brasilia; Health Sciences Faculty
  • Leandro Viana Costa e Silva University of Brasilia; Health Sciences Faculty
  • Lívia Santos Ramalho University of Brasilia; Health Sciences Faculty
  • Robelma France de Oliveira Marques National Health Surveillance Agency; Herbal and Homeopathic Medicines Coordenation
  • Dâmaris Silveira University of Brasilia; Health Sciences Faculty

DOI:

https://doi.org/10.1590/S1984-82502011000300004

Keywords:

Herbal medicines^i1^sRegulat, Herbal medicines^i1^sQuality cont, Medicines^i1^sGood Manufacture Practi, Pharmaceutical industry

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.

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Published

2011-09-01

Issue

Section

Articles

How to Cite

Regulation of herbal medicines in Brazil: advances and perspectives . (2011). Brazilian Journal of Pharmaceutical Sciences, 47(3), 467-473. https://doi.org/10.1590/S1984-82502011000300004