{"id":2842,"date":"2026-03-24T12:00:00","date_gmt":"2026-03-24T15:00:00","guid":{"rendered":"https:\/\/bye.nexsa.cl\/nuevas-exigencias-de-bioequivalencia-terapeutica-en-la-industria-farmaceutica\/"},"modified":"2026-10-06T22:17:22","modified_gmt":"2026-10-07T01:17:22","slug":"new-therapeutic-bioequivalence-requirements-in-the-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/www.bye.cl\/en\/nuevas-exigencias-de-bioequivalencia-terapeutica-en-la-industria-farmaceutica\/","title":{"rendered":"New Therapeutic Bioequivalence Requirements in the Pharmaceutical Industry"},"content":{"rendered":"<p>El Ministerio de Salud public\u00f3 el 12 de febrero de 2026 el Decreto Exento N\u00ba 9, mediante el cual se modifica la Norma T\u00e9cnica N\u00ba 136 que \u201cDetermina los principios activos contenidos en los productos farmac\u00e9uticos que deben demostrar su equivalencia terap\u00e9utica\u201d (\u201cDecreto N\u00b0 9\u201d). De esta forma, se extiende la obligaci\u00f3n de bioequivalencia a 99 nuevos principios activos y se fijan plazos obligatorios de 24 y 36 meses para la presentaci\u00f3n al Instituto de Salud P\u00fablica de la demostraci\u00f3n de bioequivalencia.<\/p>\n<p>In this regard, our Life Sciences team has prepared a detailed report, which you can access by <a href=\"\/wp-content\/uploads\/2026\/03\/Newsletter-life-sciences.pdf\">clicking here.<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>On February 12, 2026, the Ministry of Health published Exempt Decree No. 9, which amends Technical Standard No. 136, \u201cDetermining the active ingredients contained in pharmaceutical products that must demonstrate therapeutic equivalence\u201d (\u201cDecree No. 9\u201d).<\/p>","protected":false},"author":1,"featured_media":2843,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bye_card_image":2841,"_bye_lawyers":[],"_bye_areas":[77],"_bye_document":0,"_bye_document_url":"","_bye_document_label":"","_bye_old_id":28900,"_bye_old_path":"\/nuevas-exigencias-de-bioequivalencia-terapeutica-en-la-industria-farmaceutica\/","_bye_translation":"https:\/\/www.bye.cl\/new-therapeutic-bioequivalence-requirements-in-the-pharmaceutical-industry\/?lang=en","footnotes":""},"categories":[1],"tags":[],"tipo_publicacion":[7],"industria":[],"class_list":["post-2842","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sin-categoria"],"_links":{"self":[{"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/posts\/2842","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/comments?post=2842"}],"version-history":[{"count":0,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/posts\/2842\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/media\/2843"}],"wp:attachment":[{"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/media?parent=2842"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/categories?post=2842"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/tags?post=2842"},{"taxonomy":"tipo_publicacion","embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/tipo_publicacion?post=2842"},{"taxonomy":"industria","embeddable":true,"href":"https:\/\/www.bye.cl\/en\/wp-json\/wp\/v2\/industria?post=2842"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}