ABSTRACT
Potentized medicines include, according to the Brazilian legislation, homeopathic, anthroposophic, and antihomotoxic medicine and are regulated by the Brazilian Health Surveillance Agency (ANVISA). Aim: This study aims to analyze and describe a profile of potentized medicines manufactured in Brazil, either registered or notified. Methodology: Information was obtained by data analysis related to ANVISAs electronic medicine registration system. Results: The results, obtained as of September 2012, showed that 106 potentized medicines were registered and 519 were notified. Among the registered medicines, 92.0% were combined and 100.0% of the notified were simple medicines. For registered medicines, there were equivalent manufacturing scales among them, whereas for notified medicines, there was a predominance of centesimal scales. Active pharmaceutical ingredients (APIs) of vegetal origin were the most commonly used for potentized medicine manufacturing processes; the oral route was the most common form of administration. Potentized medicines manufacturing units are more often located in southeast region of Brazil. In addition, homeopathic medicines prevail as registered or notified medicines, followed by anthroposophic medicines. Conclusions: The results of the study are expected to be useful as reference material for ANVISA to improve its regulatory activity as well the industry sector and other stakeholders...
Subject(s)
Humans , Anthroposophy , Homeopathy , Legislation as Topic , Products Registration , Brazilian Health Surveillance Agency , Brazil , Complementary TherapiesABSTRACT
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.
Em 2006, dois importantes documentos foram publicados no Brasil: a Política Nacional de Práticas Integrativas e Complementares (PNPIC) no Sistema Único de Saúde (SUS) e a Política Nacional de Plantas Medicinais e Fitoterápicos (PNPMF) à luz das quais a ANVISA avaliou as normas para o setor. Como produto dessa avaliação, foram republicadas as normas para registro de medicamentos fitoterápicos, por meio da Resolução de Diretoria Colegiada (RDC) 14/10, as Boas Práticas de Fabricação e Controle de medicamentos na indústria farmacêutica, RDC 17/10, e a lista de referências para comprovação da segurança e eficácia de medicamentos fitoterápicos, na forma da Instrução Normativa (IN) 05/10. Em relação às normas anteriormente vigentes, foram atualizados os requisitos para comprovação da segurança e eficácia destes medicamentos e sugeridas alternativas ao controle da qualidade de cada etapa de produção. Dessa forma, essa revisão tem por objetivo apresentar tais normas destacando suas características principais.