{"id":1742,"date":"2026-10-06T13:02:24","date_gmt":"2026-10-06T13:02:24","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines\/m9\/"},"modified":"2026-10-06T13:02:24","modified_gmt":"2026-10-06T13:02:24","slug":"m9","status":"publish","type":"guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines\/m9\/","title":{"rendered":"M9 \u2013 Biopharmaceutics Classification System-based Biowaivers"},"content":{"rendered":"<p>This topic was endorsed by the ICH Assembly in October 2016.<\/p>\n<p>This new multidisciplinary Guideline addresses Biopharmaceutics Classification System (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognised worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions.<\/p>\n<p>This Guideline provides recommendations to support the biopharmaceutics classification of medicinal products and to support the waiver of bioequivalence studies.<\/p>\n<p>This will result in the harmonisation of current regional guidance and support streamlined global drug development.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This topic was endorsed by the ICH Assembly in October 2016. This new multidisciplinary Guideline addresses Biopharmaceutics Classification System (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1742","guideline","type-guideline","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1742","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline\/1742\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1742"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1742"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1742"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}