{"id":1661,"date":"2025-05-07T10:13:06","date_gmt":"2025-05-07T01:13:06","guid":{"rendered":"https:\/\/firm.or.jp\/en\/?page_id=1661"},"modified":"2025-06-02T16:37:27","modified_gmt":"2025-06-02T07:37:27","slug":"amlist","status":"publish","type":"page","link":"https:\/\/firm.or.jp\/en\/amlist\/","title":{"rendered":"Ancillary Materials for Regenerative Medical Products"},"content":{"rendered":"<section>\n<h2>List Publication of \u201cProducts that have received certification after undergoing the Consultation on Suitability of Ancillary Materials for Regenerative Medical Products\u201d<\/h2>\n<p>Since 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) has established a new consultation category called &#8220;Consultation on Suitability of Ancillary Materials for Regenerative Medical Products.&#8221;<br \/>\nAncillary materials whose suitability is confirmed after this consultation receive a certification from PMDA.<br \/>\nThe FIRM Supporting Industry Committee has prepared the list of \u201cProducts that have received certification after undergoing the Consultation on Suitability of Ancillary Materials for Regenerative Medical Products\u201d as outlined below:<\/p>\n<div><a href=\"https:\/\/firm.or.jp\/en\/wp-content\/uploads\/sites\/5\/2025\/06\/FIRM-List-of-Products-with-Certification-of-Suitability-for-Ancillary-Material_20250601.pdf\" target=\"_blank\">FIRM List of Products with Certification of Suitability for Ancillary Material <\/a><\/div>\n<p>However, this list is based on requests to FIRM from companies and does not comprehensively cover all the products that have obtained Certifications.<br \/>\nPlease note the following points regarding the handling of certifications from PMDA:<\/p>\n<\/section>\n<section>\uff1cNOTES\uff1e<br \/>\nExplanation of the Standards for Biological Raw Materials for human- and animal-derived ancillary materials<br \/>\n\u25cf Clinical trial initiation stage (at consultation meeting or at Clinical Trial Notification Submission)<br \/>\n&#8211; Only URL citations from the list published by FIRM (see link above) are not acceptable.<br \/>\n&#8211; A copy of the certification should be submitted as part of the consultation documents.<br \/>\n&#8211; In addition, materials such as those related to virus inactivation\/removal or other documents evaluating conformity to the Standards for Biological Raw Materials should be obtained by the supplier in order to proceed with development. Please note that the certification is not intended to eliminate the need for the exchange of such information between suppliers and sponsors\/investigators.<br \/>\n\u25cf Marketing Authorization Application Stage<br \/>\n&#8211; Only URL citations from the list published by FIRM (see link above) are not acceptable.<br \/>\n&#8211; In addition, only a copy of the certification is not acceptable. Ancillary materials such as those related to virus inactivation\/removal or other documents evaluating conformity to the Standards for Biological Raw Materials must be obtained from the supplier and submitted as attached document.<\/p>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>List Publication of \u201cProducts that have received certification after undergoing the Consultation on Suitabilit [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1661","page","type-page","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/pages\/1661","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/comments?post=1661"}],"version-history":[{"count":3,"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/pages\/1661\/revisions"}],"predecessor-version":[{"id":1675,"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/pages\/1661\/revisions\/1675"}],"wp:attachment":[{"href":"https:\/\/firm.or.jp\/en\/wp-json\/wp\/v2\/media?parent=1661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}