Post Marketing Surveillance Methods – ANVISA Brazil

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Post Marketing Survelliance Methods – ANVISA Brazil



  1. The Brazillian Health Regulatory Agency is known as Anvisa was created by Law 9782, enacted in 1999. It is a governmental regulatory agency characterized by its administrative independence, financial autonomy, and the stability of its directors. Anvisa is ruled by a Collegiate Board of Directors composed of five members.
  2. Anvisa’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients and technologies that pose any health risks.
  3. The federal, state and municipal units of sanitary surveillance that make up the National System of Sanitary Surveillance.
  4. The units of this system are the National Agency for Sanitary Surveillance (ANVISA), the National Council of State Health Secretaries (CONASS), the National Council of Municipal Health Secretaries (CONASEMS), the State, Federal District and Municipal Sanitary Surveillance Centers (VISAS), the Central Public Health Laboratories (LACENS), the National Institute for Quality Control in Health (INCQS), the Oswaldo Cruz Foundation (FIOCRUZ), and the State, District and Municipal Health Councils, in regard to sanitary surveillance actions.
  5. Anvisa coordinates the National Health Surveillance System (SNVS) and integrates the Unified Health System (SUS)
  6. Brazillian Pharmacovigilance System Image explains the flow of reporting from local centre’s to International (WHO) and Sentinel Hospitals-Components Image explains the Post marketing surveillance of Monitoring.

In BRAZIL the Postmarketing surveillance was captured as Pharmacovigilance, Technovigilance, Hemovigilance.

  1. Pharmacovigilance: The Collection, Detection, Monitoring and Prevention of Adverse Drug Reactions, Medication Errors, Rationality, Quality Deviations with Pharmaceutical products (DRUGS).
  2. Technovigilance: The Collection, Detection, Monitoring and Prevention of Adverse Events, Quality Deviations, Trainings with Medical devices, Diagnostic kits and Equipments.
  3. Hemovigilance: The Collection, Detection, Monitoring and Prevention of Adverse Reactions, Rationality with Blood and Blood Components.

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