{"id":22910,"date":"2021-02-10T02:32:09","date_gmt":"2021-02-10T02:32:09","guid":{"rendered":"https:\/\/p31noticias.com.br\/?p=22910"},"modified":"2021-02-10T02:33:09","modified_gmt":"2021-02-10T02:33:09","slug":"anvisa-e-biotech-discutem-autorizacao-para-testes-da-covaxin-no-brasil","status":"publish","type":"post","link":"https:\/\/www.p31noticias.com.br\/?p=22910","title":{"rendered":"Anvisa e Biotech discutem autoriza\u00e7\u00e3o para testes da Covaxin no Brasil"},"content":{"rendered":"<h3 class=\"col-10 offset-1 animated fadeInDown dealy-900 display-8 display-md-8 alt-font font-italic my-1 text-center\"><strong>Pedido ser\u00e1 feito quando todos os dados necess\u00e1rios forem levantados<\/strong><\/h3>\n<p style=\"text-align: justify;\">A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) se reuniu nesta segunda-feira (8) com representantes do laborat\u00f3rio indiano Bharat Biotech para definir pend\u00eancias sobre o pedido de anu\u00eancia de estudo cl\u00ednico Fase 3 da vacina Covaxin no Brasil. O pedido ainda n\u00e3o foi feito e, durante o encontro, foi definido que ele s\u00f3 ser\u00e1 formalizado pela empresa quando estiver com todos os dados necess\u00e1rios para a an\u00e1lise do pedido de estudo cl\u00ednico.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1401015&amp;o=node\" \/><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1401015&amp;o=node\" \/><\/p>\n<p style=\"text-align: justify;\">A Bharat Biotech refor\u00e7ou o desejo de realizar a Fase 3 dos estudos da Covaxin no Brasil. A reuni\u00e3o serviu para o laborat\u00f3rio e a Anvisa trocarem informa\u00e7\u00f5es sobre a documenta\u00e7\u00e3o necess\u00e1ria para formalizar o pedido de estudo cl\u00ednico no pa\u00eds. A ag\u00eancia fez o mesmo procedimento com os laborat\u00f3rios respons\u00e1veis pelas duas vacinas j\u00e1 aprovadas no pa\u00eds, a Coronavac e a vacina de Oxford.<\/p>\n<p style=\"text-align: justify;\">As pesquisas cl\u00ednicas envolvem testes em seres humanos. Os testes no Brasil, assim que aprovados, dever\u00e3o ser feitos em parceria com o Instituto Israelita de Ensino e Pesquisa do Hospital Albert Einstein. Ser\u00e3o em torno de 3 mil volunt\u00e1rios testados em cinco centros de refer\u00eancia. A autoriza\u00e7\u00e3o da Anvisa \u00e9 obrigat\u00f3ria para pesquisas de medicamentos e vacinas realizadas no Brasil e que tenham como foco o futuro registro no pa\u00eds.<\/p>\n<p style=\"text-align: justify;\">\u201cDurante a reuni\u00e3o da segunda-feira, os especialistas da Ag\u00eancia apontaram quais documentos e informa\u00e7\u00f5es precisam ser enviados e os ajustes necess\u00e1rios aos documentos j\u00e1 apresentados, com base na legisla\u00e7\u00e3o sanit\u00e1ria brasileira\u201d, disse a Anvisa em nota. Segundo o comunicado, a realiza\u00e7\u00e3o de estudos cl\u00ednicos no pa\u00eds permite que a pr\u00f3pria ag\u00eancia, assim como os pesquisadores brasileiros, acompanhem o desenvolvimento cl\u00ednico.<\/p>\n<p>Fonte : Ag\u00eancia Brasil<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pedido ser\u00e1 feito quando todos os dados necess\u00e1rios forem levantados A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) se reuniu nesta segunda-feira (8) com representantes do laborat\u00f3rio indiano Bharat Biotech para definir pend\u00eancias sobre o pedido de anu\u00eancia de estudo cl\u00ednico Fase 3 da vacina Covaxin no Brasil. O pedido ainda n\u00e3o foi feito e, durante [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":22911,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[68],"tags":[],"class_list":{"0":"post-22910","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-brasil"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Anvisa e Biotech discutem autoriza\u00e7\u00e3o para testes da Covaxin no Brasil - P31<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.p31noticias.com.br\/?p=22910\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa e Biotech discutem autoriza\u00e7\u00e3o para testes da Covaxin no Brasil\" \/>\n<meta property=\"og:description\" content=\"Pedido ser\u00e1 feito quando todos os dados necess\u00e1rios forem levantados A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) se reuniu nesta segunda-feira (8) com representantes do laborat\u00f3rio indiano Bharat Biotech para definir pend\u00eancias sobre o pedido de anu\u00eancia de estudo cl\u00ednico Fase 3 da vacina Covaxin no Brasil. 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