PAHO published Questions and answers (Q&A) on regulatory matters related to the introduction and pharmacovigilance of vaccines against COVID-19, available at PAHOIMSHSSMTCOVID-19210001_eng.pdf
On Monday (30/11), Anvisa was formally informed of the successful completion of the Agency’s process of adhering to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Anvisa will become the 54th member of the international initiative in pharmaceutical inspection, and will have the international recognition of the excellence of inspections in Good Manufacturing Practices (GMP) of medicines and pharmaceutical inputs for human use.
This document, which is an update of the guidance published on 5 June 2020, includes new scientific evidence relevant to the use of masks for reducing the spread of SARS-CoV-2, the virus that causes COVID-19, and practical considerations. It contains updated evidence and guidance on the following:
• mask management;
• SARS-CoV-2 transmission;
• masking in health facilities in areas with community, cluster and sporadic transmission;
• mask use by the public in areas with community and cluster transmission;
• alternatives to non-medical masks for the public;
• exhalation valves on respirators and non-medical masks;
• mask use during vigorous intensity physical activity;
• essential parameters to be considered when manufacturing non-medical masks (Annex).
Mask use in the context of COVID-19: interim guidance, 1 December 2020 (who.int)
Date:
December 2, 2020
Time:
12:15 PM – 1:15 PM ET
Health Canada and COVID-19 health product industry
26/11/2020 16h53
Empresa Pfizer protocolou documentos relativos às fases não-clínicas e clínicas I e II. A submissão contínua ainda não é o pedido de registro.
26/11/2020 13h50
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!
25/11/2020 09h48
Problema pode ser agravado e acelerado por conta do uso indevido de antibióticos.
20/11/2020 09h25
Brasil irá inspecionar as plantas de produção específicas das vacinas contra Covid-19 na China.
https://www.gov.br/anvisa/pt-br/assuntos/paf/coronavirus
Cofepris actions on Covid-19 (In Spanish)
https://www.gob.mx/cofepris/acciones-y-programas/acciones-sobre-covid-19?state=published
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.
You could download the document directly by clicking on the following link: https://www.who.int/biologicals/Collaborative_Procedure_for_IVDs_for_PC.pdf?ua=1
In order to provide your comments, please use the template, https://www.who.int/biologicals/Comment_Form_CRP_diagnostics_June_2020.doc?ua=1
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 1 April 2020
We invite you to participate in this virtual seminar to present and discuss PAHO’s ethics guidance for COVID-19 research available at: https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic.
To participate follow this link: https://paho.webex.com/paho/onstage/g.php?MTID=eb1e5b00997fab7e37c834c5d35d9ad3f
Tuesday March 31 2:00 – 3:30 pm, Washington D.C. time (In English)
We are waiting for you.
PANDRH Secretariat
