alexa Brazilian Regulation in Pharmacovigilance: A Review
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Brazilian Regulation in Pharmacovigilance: A Review

De Carvalho PM*, Varallo FR and Dagli-Hernandez C

Department of Drugs and Medications, School of Pharmaceutical Sciences, University of Estadual Paulista, Araraquara, Sao Paulo, Brazil

*Corresponding Author:

De Carvalho PM
Department of Drugs and Medications
School of Pharmaceutical Sciences
University of Estadual Paulista, Araraquara
Sao Paulo, Brazil
Tel: +55 16 3301-6977
Fax: +55 16 3322-0073
E-mail: [email protected]

Received Date: April 25, 2016; Accepted Date: May 13, 2016; Published Date: May 18, 2016

Citation: De Carvalho PM, Varallo FR, Dagli-Hernandez C (2016) Brazilian Regulation in Pharmacovigilance: A Review. Pharmaceut Reg Affairs 5:164. doi:10.4172/2167-7689.1000164

Copyright: © 2016 De Carvalho PM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Brazilian health legislation on drug surveillance has been available for only four decades. This study aimed to analyze the chronological evolution of the pharmacovigilance legislation in Brazil. A critical review of the legislations and communications published between 1976 and 2015 was conducted. Sixty-two (62) documents were identified. Advancements in the assessment of health technologies occurred only after the publication of the National Drug Policy (1998), the foundation of the National Health Surveillance Agency (ANVISA), and the creation of the National Center for Drug Monitoring (2001). From 2009, pharmacovigilance practices became mandatory for marketing authorization holders. Despite recent, the regulatory advancements in pharmacovigilance in Brazil are equivalent to international practices. However, there is still a lack of regulations for biosimilars and veterinary medicines, of agility in reporting non-serious risks to manufacturers and health care services, and of encouragement for reporting technical complaints and quality deviations, which could improve and control post-marketing drug quality. It is necessary to encourage and develop strategies for the decentralization of pharmacovigilance actions to the whole country.


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