{"id":1643,"date":"2020-12-22T11:51:54","date_gmt":"2020-12-22T14:51:54","guid":{"rendered":"https:\/\/redenoticiaz.com.br\/litoralsp\/2020\/12\/22\/anvisa-certifica-farmaceutica-chinesa-da-coronavac\/"},"modified":"2020-12-22T11:55:20","modified_gmt":"2020-12-22T14:55:20","slug":"anvisa-certifica-farmaceutica-chinesa-da-coronavac","status":"publish","type":"post","link":"https:\/\/redenoticiaz.com.br\/litoralsp\/2020\/12\/22\/anvisa-certifica-farmaceutica-chinesa-da-coronavac","title":{"rendered":"Anvisa certifica farmac\u00eautica chinesa da CoronaVac"},"content":{"rendered":"<p>A Sinovac, f\u00e1brica que desenvolveu a vacina CoronaVac contra o novo coronav\u00edrus, em parceria com o Instituto Butantan, de S\u00e3o Paulo, recebeu a certifica\u00e7\u00e3o de boas pr\u00e1ticas da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa).<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1397069&amp;o=node\" \/><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1397069&amp;o=node\" \/><\/p>\n<p>A resolu\u00e7\u00e3o foi publicada pela Anvisa nesta segunda-feira (21) no\u00a0<a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-re-n-5.300-de-21-de-dezembro-de-2020-295445420\" target=\"_blank\" rel=\"noopener noreferrer\"><em>Di\u00e1rio Oficial da Uni\u00e3o<\/em><\/a>, tem validade de dois anos e diz respeito \u00e0 linha de produ\u00e7\u00e3o do Insumo Farmac\u00eautico Ativo (IFA) &#8211; mat\u00e9ria-prima para a produ\u00e7\u00e3o do imunizante e de produtos est\u00e9reis usados na formula\u00e7\u00e3o.<\/p>\n<p>&#8220;A etapa finalizada \u00e9 um dos pr\u00e9-requisitos para a continuidade do processo de registro da vacina da Sinovac e de um eventual pedido de autoriza\u00e7\u00e3o&#8221;, ressaltou a ag\u00eancia, em nota divulgada na noite de ontem. O pedido de registro, no entanto, depende da divulga\u00e7\u00e3o de resultados sobre a efic\u00e1cia da vacina. Sendo assim, o Butantan, promete fazer o registro dos resultados amanh\u00e3 (23).<\/p>\n<h2>Hist\u00f3rico<\/h2>\n<p>A certifica\u00e7\u00e3o da farmac\u00eautica chinesa foi dada a cerca de 10 dias antes do prazo previsto inicialmente. Antes de conceder o documento, uma equipe de t\u00e9cnicos da ag\u00eancia foi a Pequim, na China, fazer inspe\u00e7\u00e3o em uma f\u00e1brica da Sinovac. A visita tinha por objetivo avaliar a qualidade da linha de produ\u00e7\u00e3o. Ap\u00f3s a visita , que ocorreu entre os dias 30 de novembro e 4 de dezembro, foi encaminhado um relat\u00f3rio \u00e0 Sinovac e ao Instituto Butantan com as conclus\u00f5es.<\/p>\n<p>&#8220;O plano de a\u00e7\u00e3o foi enviado pelo Instituto Butantan para a Anvisa na \u00faltima quarta-feira (16). J\u00e1 a avalia\u00e7\u00e3o t\u00e9cnica da equipe inspetora e a revis\u00e3o t\u00e9cnica foram realizadas e conclu\u00eddas no final desta semana. Assim, foram antecipados em cerca de 10 dias da previs\u00e3o inicial a publica\u00e7\u00e3o da decis\u00e3o sobre a certifica\u00e7\u00e3o&#8221;, informou a Anvisa.<\/p>\n<h2>Oxford<\/h2>\n<p>Na mesma viagem \u00e0 China, os t\u00e9cnicos da Anvisa tamb\u00e9m inspecionaram a f\u00e1brica que produzir\u00e1 a mat\u00e9ria-prima que ser\u00e1 enviada ao Brasil. Elementos usados para a produ\u00e7\u00e3o da vacina de Oxford\/AstraZeneca, pela Funda\u00e7\u00e3o Oswaldo Cruz (Fiocruz). Nesse caso, a certifica\u00e7\u00e3o deve sair at\u00e9 o in\u00edcio de janeiro, segundo a ag\u00eancia.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>LEIA TAMB\u00c9M<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/redenoticiaz.com.br\/blog\/2020\/12\/22\/sp-contrata-2-500-cameras-corporais-para-a-pm\/\">SP contrata 2.500 c\u00e2meras corporais para a PM<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Sinovac, f\u00e1brica que desenvolveu a vacina CoronaVac contra o novo coronav\u00edrus, em parceria com o Instituto Butantan, de S\u00e3o Paulo, recebeu a certifica\u00e7\u00e3o de boas pr\u00e1ticas da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa). A resolu\u00e7\u00e3o foi publicada pela Anvisa nesta segunda-feira (21) no\u00a0Di\u00e1rio Oficial da Uni\u00e3o, tem validade de dois anos e diz respeito &hellip;<\/p>\n","protected":false},"author":5,"featured_media":1644,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[4052,5524,1949],"class_list":["post-1643","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude","tag-butantan","tag-certificacao-anvisa","tag-sinovac"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa certifica farmac\u00eautica chinesa da CoronaVac - Litoral SP<\/title>\n<meta name=\"description\" content=\"A Sinovac, f\u00e1brica que desenvolveu a vacina CoronaVac contra o novo coronav\u00edrus, em parceria com o Instituto Butantan, de S\u00e3o Paulo, recebeu a\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/redenoticiaz.com.br\/litoralsp\/2020\/12\/22\/anvisa-certifica-farmaceutica-chinesa-da-coronavac\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa certifica farmac\u00eautica chinesa da CoronaVac - 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