Show simple item record

dc.date.accessioned2020-08-12T14:37:48Z
dc.date.available2020-08-12T14:37:48Z
dc.date.issued2020-08-12
dc.identifier.govdocPAHO/HSS/MT/COVID-19/20-0026
dc.identifier.urihttps://iris.paho.org/handle/10665.2/52578
dc.description.abstractThe 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.en_US
dc.language.isoenen_US
dc.publisherPAHOen_US
dc.rightsAttribution-NonCommercial-ShareAlike 3.0 IGO*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/3.0/igo/*
dc.subjectCOVID-19en_US
dc.subjectCoronavirusen_US
dc.subjectAccess to Essential Medicines and Health Technologiesen_US
dc.subjectPandemicsen_US
dc.subjectInfection Controlen_US
dc.titlePost-authorization Surveillance of Medical Products during a Pandemic Emergency, 21 July 2020en_US
dc.typeProcedures, manuals, guidelinesen_US
dc.rights.holderPan American Health Organizationen_US
dc.contributor.corporatenamePan American Health Organizationen_US
paho.isfeatured0en_US
paho.publisher.countryUnited Statesen_US
paho.publisher.cityWashington, D.C.en_US
paho.source.centercodeUS1.1en_US
paho.relation.languageVersion10665.2/52513en_US
paho.contributor.departmentHealth Systems and Services (HSS)en_US
paho.iswhotranslationNoen_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record

Attribution-NonCommercial-ShareAlike 3.0 IGO
This notice should be preserved along with the article's original URL.Attribution-NonCommercial-ShareAlike 3.0 IGO