Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Brazilian Regulation in Pharmacovigilance: A Review


De Carvalho PM, Varallo FR and Dagli-Hernandez C

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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