IMPLEMENTATION OF ACTIVE PHARMACOVIGILANCE SYSTEMS IN HEALTH SERVICES AND PHARMACEUTICAL INDUSTRIES: A CRITICAL ANALYSIS OF ANVISA’S REQUIREMENTS

Abstract

This chapter aims to critically analyze the implementation of active pharmacovigilance systems in healthcare services and pharmaceutical industries in light of the regulatory requirements established by the National Health Surveillance Agency (ANVISA). A qualitative approach was adopted, based on documentary research and a narrative review of scientific literature and current Brazilian regulatory frameworks. The findings indicate that active pharmacovigilance represents a strategic advancement in the early detection of adverse events, enhancing patient safety and improving risk management processes. However, challenges were identified, including the standardization of procedures, professional training, integration of information systems, and the strengthening of a reporting culture within institutions. It is concluded that compliance with ANVISA’s requirements requires not only regulatory alignment but also investments in clinical governance, health information technologies, and shared sanitary responsibility between public and private sectors.