{"id":68594,"date":"2024-03-22T11:27:39","date_gmt":"2024-03-22T14:27:39","guid":{"rendered":"https:\/\/cdpipharma.com.br\/?p=68594"},"modified":"2024-03-22T11:45:38","modified_gmt":"2024-03-22T14:45:38","slug":"avancos-tecnologicos-que-impulsionam-o-desenvolvimento-analitico-na-industria-farmaceutica-2","status":"publish","type":"post","link":"https:\/\/cdpipharma.com.br\/materias\/avancos-tecnologicos-que-impulsionam-o-desenvolvimento-analitico-na-industria-farmaceutica-2\/","title":{"rendered":"Publicada a RDC 851\/24, que altera a RDC 73\/16 sobre p\u00f3s-registro de medicamentos"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"68594\" class=\"elementor elementor-68594\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-091e66c e-flex e-con-boxed e-con e-parent\" data-id=\"091e66c\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0daa12b elementor-widget elementor-widget-text-editor\" data-id=\"0daa12b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.21.0 - 30-04-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Fonte: Reda\u00e7\u00e3o CDPI<\/strong><\/p><p style=\"text-align: justify;\">Nova RDC 851\/24 altera p\u00f3s-registro de medicamentos sint\u00e9ticos<\/p><p style=\"text-align: justify;\">O Di\u00e1rio Oficial publicou hoje (22\/03) a RDC 851, DE 20 DE MAR\u00c7O DE 2024, alterando a RDC 73\/16, que disp\u00f5e sobre mudan\u00e7as de p\u00f3s-registro e cancelamento de registro de medicamentos com princ\u00edpios ativos sint\u00e9ticos e semissint\u00e9ticos.<\/p><p style=\"text-align: justify;\">As mudan\u00e7as, incluem nova concentra\u00e7\u00e3o para medicamentos novos e inovadores registrados, na mesma forma farmac\u00eautica, al\u00e9m de inclus\u00e3o de nova concentra\u00e7\u00e3o para medicamentos gen\u00e9ricos e similares.<\/p><p style=\"text-align: justify;\">A nova RDC entra em vigor em 01 de maio deste ano e determina que as peti\u00e7\u00f5es de p\u00f3s-registro protocoladas antes da data de vig\u00eancia desta Resolu\u00e7\u00e3o, ou que j\u00e1 se encontram em an\u00e1lise na Anvisa, ser\u00e3o analisadas conforme as Resolu\u00e7\u00f5es vigentes \u00e0 \u00e9poca do protocolo.<\/p><p style=\"text-align: justify;\">J\u00e1 as peti\u00e7\u00f5es que atendam aos requisitos da RDC 851\/24, e tenham sido protocoladas anteriormente \u00e0 sua vig\u00eancia, poder\u00e3o ser avaliadas nos termos desta Resolu\u00e7\u00e3o.<\/p><p style=\"text-align: justify;\">Para os medicamentos em desenvolvimento at\u00e9 maio de 2024, ser\u00e1 aceito o desenvolvimento previamente acordado, conforme o prazo definido no instrumento de formaliza\u00e7\u00e3o do\u00a0acordo.<\/p><h4 style=\"text-align: justify;\">Saia na frente<\/h4><p style=\"text-align: justify;\">Diante desse cen\u00e1rio de mudan\u00e7as r\u00e1pidas e complexas, programas de especializa\u00e7\u00e3o, como a P\u00f3s-gradua\u00e7\u00e3o em Assuntos Regulat\u00f3rios com \u00eanfase em CMC e Internacional do CDPI Pharma, tornam-se essenciais para capacitar profissionais a lidar de forma proativa com as normas t\u00e9cnicas e regulat\u00f3rias que regem a ind\u00fastria farmac\u00eautica, destacando o papel estrat\u00e9gico desses profissionais nos processos de aprova\u00e7\u00e3o de\u00a0medicamentos.<\/p><p style=\"text-align: justify;\"><a href=\"https:\/\/cdpipharma.com.br\/cursos\/pos-graduacao\/pos-graduacao-em-assuntos-regulatorios-enfase-internacional-e-cmc-on-line-ao-vivo\/\">Clique aqui e conhe\u00e7a a P\u00f3s-gradua\u00e7\u00e3o em Assuntos regulat\u00f3rios com \u00eanfase em CMC e Internacional.<\/a><\/p><p style=\"text-align: justify;\">Participe do nosso grupo de WhatsApp para receber not\u00edcias relacionadas \u00e0 ind\u00fastria farmac\u00eautica.<\/p><p><a href=\"https:\/\/chat.whatsapp.com\/HdaOs3wFFdW923huMux8w0\"><strong>\u00a0Clique aqui e fa\u00e7a parte do seleto grupo CDPI Not\u00edcias.<\/strong><\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Fonte: Reda\u00e7\u00e3o CDPI Nova RDC 851\/24 altera p\u00f3s-registro de medicamentos sint\u00e9ticos O Di\u00e1rio Oficial publicou hoje (22\/03) a RDC 851,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":68608,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","footnotes":""},"categories":[115],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.6 - 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