Regulation of herbal medicines in Brazil: advances and perspectives

被引：21

作者：

Bezerra Carvalho, Ana Cecilia ^{[1
,2
]}

Silverio Perfeito, Joao Paulo ^{[1
,2
]}

Costa e Silva, Leandro Viana ^{[1
,2
]}

Ramalho, Livia Santos ^{[1
,2
]}

de Oliveira Marques, Robelma France ^{[1
]}

Silveira, Damaris ^{[2
]}

机构：

[1] Univ Brasilia, Natl Hlth Surveillance Agcy ANVISA, BR-70910900 Brasilia, DF, Brazil

[2] Univ Brasilia, Fac Hlth Sci, BR-70910900 Brasilia, DF, Brazil

来源：

BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2011年 / 47卷 / 03期

关键词：

Herbal medicines; Regulation; Quality control; Medicines; Good Manufacture Practices; Pharmaceutical industry;

D O I：

10.1590/S1984-82502011000300004

中图分类号：

R9 [药学];

学科分类号：

100702 [药剂学];

摘要：

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.

引用

页码：467 / 473

页数：7

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