{"id":1862,"date":"2026-10-06T13:36:48","date_gmt":"2026-10-06T13:36:48","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/reflection-papers\/harmonization-of-standards-for-generic-drugs\/"},"modified":"2026-10-06T13:36:48","modified_gmt":"2026-10-06T13:36:48","slug":"harmonization-of-standards-for-generic-drugs","status":"publish","type":"reflection_paper","link":"https:\/\/dev.ich.org\/index.php\/reflection-papers\/harmonization-of-standards-for-generic-drugs\/","title":{"rendered":"Harmonization of Standards for Generic Drugs"},"content":{"rendered":"<p>This Reflection Paper was endorsed by the Assembly in November 2018.<\/p>\n<p>Harmonization of technical and scientific standards for generic drugs presents an opportunity for significant public health benefits by streamlining drug development across regulatory jurisdictions and increasing patient access globally to high quality affordable pharmaceuticals. This ICH Reflection Paper outlines a strategic approach for developing and enhancing ICH Guidelines to support the harmonization of scientific and technical standards for generic drugs. As part of this approach, this paper outlines recommendations to develop a series of ICH Guidelines on standards for demonstrating equivalence (e.g., bioequivalence) for (1) non-complex dosage forms and (2) more complex dosage forms and products.<\/p>\n<p>This ICH Reflection Paper furthermore describes, in the annex, the remit of the Generic drug Discussion Group (GDG), which will serve for issues relevant to harmonisation of scientific and technical standards for generic drugs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This ICH Reflection Paper outlines a strategic approach for developing and enhancing ICH Guidelines to support the harmonization of scientific and technical standards for generic drugs.<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[20],"guideline_tag":[],"rd_phase":[],"class_list":["post-1862","reflection_paper","type-reflection_paper","status-publish","hentry","guideline_category-multidisciplinary"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper\/1862","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/reflection_paper"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/reflection_paper\/1862\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1862"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1862"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1862"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}