{"id":3218,"date":"2015-04-01T00:00:00","date_gmt":"2015-04-01T03:00:00","guid":{"rendered":"https:\/\/ids.org.br\/novo-site\/en\/brazilian-drug-approval-considerations\/"},"modified":"2015-04-01T00:00:00","modified_gmt":"2015-04-01T03:00:00","slug":"brazilian-drug-approval-considerations","status":"publish","type":"post","link":"https:\/\/ids.org.br\/en\/brazilian-drug-approval-considerations\/","title":{"rendered":"Brazilian drug approval considerations"},"content":{"rendered":"<p style=\"text-align: justify\"><em><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\">Gustavo de Freitas Morais<br \/>\nRodrigo Augusto Oliveira Rocci<br \/>\nand Vyctor Taddeucci de Ara&uacute;jo<\/span><\/span><\/span><\/em><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\"><br \/>\n<\/span><strong><span style=\"font-family: Verdana\">Introduction<\/span><\/strong><\/span><\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\">The Brazilian patent system is ruled by Brazilian Patent Office created by Federal Law n&ordm; 5.648\/70 and its authority is defined by Brazilian Industrial Property Law (no. 9.279\/96). On the Brazilian health regulatory system introduced by Act no 6.360\/76, any drug may be marketed only if it has been previously registered with the pertinent authority of the Ministry of Health; such competence was<br \/>\nattributed to Brazilian Agency of Sanitary Surveillance (&ldquo;ANVISA&rdquo;) by Law no 9.782\/99.<\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\">As can be noticed, pharmaceuticals in Brazil are governed by a comprehensive and complex regime of legislation and regulations spanning many different areas of law. The legislative and regulatory landscapes are very dynamic, as patent laws are constantly under review and government authorities constantly update regulatory processes and policies.<\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\">This chapter provides an overview of each element in this complex Brazilian regime together with insights into the issues that might arise and how they might be navigated.<\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify\"><strong><span style=\"color: #505050\"><span style=\"font-size: x-small\"><span style=\"font-family: Verdana\"><a href=\"https:\/\/www.dannemann.com.br\/dsbim\/uploads\/imgFCKUpload\/file\/Derechos_Farmaceuticos_ASIPI.pdf\">Full Article<\/a><\/span><\/span><\/span><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gustavo de Freitas Morais Rodrigo Augusto Oliveira Rocci and Vyctor Taddeucci de Ara&uacute;jo Introduction The Brazilian patent system is ruled by Brazilian Patent Office created by Federal Law n&ordm; 5.648\/70 and its authority is defined by Brazilian Industrial Property Law (no. 9.279\/96). On the Brazilian health regulatory system introduced by Act no 6.360\/76, any drug [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[117,95,93],"tags":[148,139],"acf":[],"_links":{"self":[{"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/posts\/3218"}],"collection":[{"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/comments?post=3218"}],"version-history":[{"count":0,"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/posts\/3218\/revisions"}],"wp:attachment":[{"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/media?parent=3218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/categories?post=3218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ids.org.br\/en\/wp-json\/wp\/v2\/tags?post=3218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}