Murilo Freitas - 17:23, 5 de February de 20214,061
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USP is hosting a Global Seminar Series, Ensuring Quality Hand Sanitizer Production During COVID-19, to help ensure quality alcohol-based hand sanitizer production and support the safe use of alcohol-based hand sanitizer, February 25th, 2021.
Murilo Freitas - 19:53, 29 de January de 20211,203
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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
Murilo Freitas - 19:47, 1 de December de 20202,336
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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.
Murilo Freitas - 19:45, 1 de December de 20201,505
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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).
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!
Fernanda Lessa - 11:37, 10 de November de 20203,110
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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.
