The United States Pharmacopeia published “COVID-19 Vaccine Handling Toolkit: Operational Considerations for Healthcare Practitioners”, available at https://www.usp.org/covid-19/vaccine-handling-toolkit.
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
In March 2020, the European Medicines Agency (EMA) informed that it would no longer provide printed Certificates of Pharmaceutical Products (CPP) but only electronically signed and authenticated ones, that would enable EMA to continue to be able provide certificates during the COVID-19 pandemic. The Agency considers electronic CPPs as the permanent way of issuing certificates.
EMA published a guidance on the format and safety features of the electronic certificates, as well on as measures to help regulatory authorities of importing countries confirm their validity. It also produced an official letter with information that might be useful for regulators when handling the electronic certificates.
On the use of electronic CPPs, WHO agrees with this initiative, which does not contradict the current guidelines. The Organization recommends other regulators issuing certificates consider this approach too, and urges regulators receiving certificates to accept the electronic signature.
The WHO has published the draft “COVID-19 Vaccines: Safety Surveillance Manual” for public consultation. Comments and suggestions shall be sent to lamprianous@who.int, no later than 13 November 2020, 12 PM CET.
This COVID-19 vaccine safety surveillance manual has been developed upon recommendation and guidance of Global Advisory Committee on Vaccine Safety (GACVS) members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
Such manual provides relevant guidance prior to, during and after COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, partners and pharmacovigilance centers as well as marketing authorization holders.
Further information at: https://www.who.int/vaccine_safety/committee/covid_vaccine_safety_manual/en/
