[The National Health Surveillance Agency, ANVISA, and clinical research in Brazil]. / A Agência Nacional de Vigilância Sanitária e a pesquisa clínica no Brasil.
Rev Assoc Med Bras (1992)
; 52(1): 60-2, 2006.
Article
em Pt
| MEDLINE
| ID: mdl-16622542
Conduction of clinical trials with drugs in Brazil requires prior approval by Committees for Ethics in Research (CEPs) and, in certain cases, by the National Commission for Ethics in Research (CONEP). Approval by the National Health Surveillance Agency (ANVISA), through its Office for New Drugs, Research and Clinical Trials (GEPEC), is currently required only for drugs and medical devices manufactured in other countries and therefore need permission to be imported. This article briefly reviews the history of clinical research regulation in Brazil, then presents an overview of the current regulatory role of ANVISA and its future prospective. Major points discussed are the new forthcoming ANVISA regulations, with emphasis on adverse event notifications and inspections/audits on clinical trials and their impact on clinical research in Brazil, from the standpoint of the industry, university, contract research organizations, physicians and other health professionals. It should be stressed that to decide upon the licensing of new drugs ANVISA must obtain information from clinical trials.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Comitês de Ética em Pesquisa
/
Pesquisa Biomédica
/
Órgãos Governamentais
Tipo de estudo:
Prognostic_studies
/
Screening_studies
Aspecto:
Ethics
Limite:
Humans
País/Região como assunto:
America do sul
/
Brasil
Idioma:
Pt
Revista:
Rev Assoc Med Bras (1992)
Ano de publicação:
2006
Tipo de documento:
Article
País de publicação:
Brasil