Post-authorization Surveillance of Medical Products during a Pandemic Emergency, 21 July 2020

Post-authorization Surveillance of Medical Products during a Pandemic Emergency, 21 July 2020

The purpose of this report is to furnish guidance and recommendations to support regulatory decision-making in pharmacovigilance, technovigilance, and hemovigilance during pandemics in the Region of the Americas. Furthermore, given the heightened importance of improving the detection, prevention, and response to unregistered, substandard, or falsified medical products in this context, it addresses key issues in this regard. This report is designed for national regulatory authorities (NRAs) and other actors (Expanded Program on Immunization, disease-specific and public health programs, health service professionals, etc.)