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

ABSTRACT

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.) involved in the regulation, selection, indication, and utilization of health technologies. Although this report discusses both medicines (including vaccines) and medical devices, the steps prior to their use and conditions of authorization, as well as post-authorization surveillance, are clearly very different for each of these health technologies. Since post-authorization surveillance is a regulatory function of the health authorities, the report describes common approaches for the different types of technologies, as well as aspects specific to each one. The market surveillance components associated with importation/exportation, distribution, regulation of promotion and advertising, quality control, and inspection are beyond the scope of this report, unless they are related to the main components mentioned.