Na terça-feira (1º/12), às 15h, a Agência irá realizar um seminário virtual sobre as ações de farmacovigilância no enfrentamento da Covid-19. Participe!
WHO has a public consultation on the following document for the WHO Expert Committee on Biological Standardization (ECBS) is now open.
WHO assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)
The 1st draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) has been prepared to enhance timely access to WHO-prequalified products in countries, to ensure that the product in countries is the same as the one which is WHO-prequalified and to provide a model for regulatory information exchange between countries. The draft document has been updated based on the informal consultation with experts from the National Regulatory Authorities which was conducted in November 2019 during the WHO Workshop on Collaborative Registration Procedure for Diagnostics.
WHO are now publishing this draft to get the feedback from a broad audience of relevant government authorities, manufacturers, and other experts. DEADLINE for submission of comment: 15 July 2020. Please send comments to: gunlud@who.int.
TOPIC: Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders – Do Not Use as Treatment for COVID-19 in Humans
AUDIENCE: Consumer, Health Professional
ISSUE: The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Unfortunately, we have learned that one person in the United States has died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19; his wife also became very ill.
Our primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs.
This document provides interim guidance on the management of the blood supply in response to the pandemic outbreak of coronavirus disease (COVID-19). It is intended for blood services, national health authorities, and others responsible for the provision of blood and blood components and integration of the blood system within the public health system. WHO will continue to update this guidance as new information becomes available.
