Nesta segunda-feira (30/11), a Anvisa foi formalmente comunicada da conclusão, com sucesso, do processo de adesão da Agência ao Esquema de Cooperação em Inspeção Farmacêutica (PIC/S, do inglês Pharmaceutical Inspection Co-operation Scheme). A Anvisa se tornará o 54º membro da iniciativa internacional em inspeção farmacêutica, passando a contar com o reconhecimento internacional da excelência das inspeções em Boas Práticas de Fabricação (BPF) de medicamentos e insumos farmacêuticos de uso humano.

https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/anvisa-e-aprovada-para-cooperacao-em-inspecao-farmaceutica-2013-pic-s

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

Virtual Town Hall Series – Coronavirus (COVID-19) Test Development and Validation – 12/02/2020 – 12/02/2020 | FDA

Health Canada and COVID-19 health product industry

COVID-19 health product industry – Canada.ca

https://www.gov.br/anvisa/pt-br/assuntos/paf/coronavirus

Ações de Cofepris sobre Covid-19 (em Espanhol)

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

Lo invitamos a participar en este seminario virtual donde se presentará y discutirá la orientación ética para la investigación sobre COVID-19 de la OPS disponible en: https://www.paho.org/es/documentos/orientacion-etica-sobre-cuestiones-planteadas-por-pandemia-nuevo-coronavirus-covid-19.

Hoy, 30 de marzo, de 2 a 3:30pm (hora de Washington, DC)

Para participar diríjase a: https://paho.webex.com/paho/onstage/g.php?MTID=e9bcc2a227ad498f78625158a65422143

Aguardamos a todos.

Saludos cordiales,

Secretariado Red PARF