{"id":1765,"date":"2026-10-06T13:11:35","date_gmt":"2026-10-06T13:11:35","guid":{"rendered":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/s5-r4\/"},"modified":"2026-10-06T13:11:35","modified_gmt":"2026-10-06T13:11:35","slug":"s5-r4","status":"publish","type":"draft_guideline","link":"https:\/\/dev.ich.org\/index.php\/guidelines-under-development\/s5-r4\/","title":{"rendered":"S5(R4) \u2013 Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals"},"content":{"rendered":"<p>In March 2019, the ICH Management Committee approved the establishment of a maintenance procedure for the S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals. The maintenance procedure (attached on this page) aimed to facilitate proper implementation of novel testing paradigms and regulatory acceptance of alternative assays supporting global 3R (replacement, reduction, refinement) efforts, accelerating the harmonisation of its context of use across regions and the communication between applicants and assessors. No proposals for revisions of Annex 1 or 2 have been received and therefore the group has been disbanded in November 2024.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In March 2019, the ICH Management Committee approved the establishment of a maintenance procedure for the S5 Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals. The maintenance procedure\u2026<\/p>\n","protected":false},"featured_media":0,"template":"","guideline_category":[19],"guideline_tag":[],"rd_phase":[],"class_list":["post-1765","draft_guideline","type-draft_guideline","status-publish","hentry","guideline_category-safety"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1765","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/draft_guideline"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/draft_guideline\/1765\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=1765"}],"wp:term":[{"taxonomy":"guideline_category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_category?post=1765"},{"taxonomy":"guideline_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/guideline_tag?post=1765"},{"taxonomy":"rd_phase","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/rd_phase?post=1765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}