{"id":8793,"date":"2025-10-17T16:24:27","date_gmt":"2025-10-17T08:24:27","guid":{"rendered":"https:\/\/regask.com\/?p=8793"},"modified":"2025-10-17T16:24:27","modified_gmt":"2025-10-17T08:24:27","slug":"%e7%b1%b3%e5%9b%bd%e3%81%ae%e3%82%b8%e3%82%a7%e3%83%8d%e3%83%aa%e3%83%83%e3%82%af%e5%8c%bb%e8%96%ac%e5%93%81%e8%a3%bd%e9%80%a0%e3%81%ae%e6%9c%aa%e6%9d%a5%e3%82%92%e5%a4%89%e3%81%88%e3%82%8b%e5%8f%af","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/new-fda-pilot-program-that-could-reshape-the-future-of-u-s-generic-drug-manufacturing\/","title":{"rendered":"\u2026\u306e\u672a\u6765\u3092\u5909\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b FDA \u306e\u65b0\u3057\u3044\u30d1\u30a4\u30ed\u30c3\u30c8 \u30d7\u30ed\u30b0\u30e9\u30e0"},"content":{"rendered":"<p>The <a href=\"https:\/\/www.fda.gov\/\"><strong>U.S. Food and Drug Administration (FDA)<\/strong><\/a> has announced a <strong>pilot prioritization program<\/strong> for <strong>Abbreviated New Drug Applications (ANDAs)<\/strong> that supports <strong>domestic manufacturing and testing<\/strong>. The initiative, launched on <strong>October 3, 2025<\/strong>, aims to <strong>expedite review timelines<\/strong> for qualifying applications, <strong>reduce foreign dependency<\/strong>, and <strong>boost the resilience of the U.S. pharmaceutical supply chain<\/strong>.<\/p>\n<p>Under the pilot, generic drug manufacturers who conduct <strong>bioequivalence testing within the United States<\/strong>, produce <strong>finished dosage forms domestically<\/strong>, and source <strong>active pharmaceutical ingredients (APIs)<\/strong> exclusively from <strong>U.S.-based suppliers<\/strong> are eligible for <strong>priority review<\/strong>.<\/p>\n<p>This measure addresses both <strong>public health and national security risks<\/strong> by strengthening domestic R&amp;D capabilities and reducing the inspection of costs and delays associated with overseas manufacturing facilities.<\/p>\n<div class=\"row\"  id=\"row-379756210\">\n\n\t<div id=\"col-580100225\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Key Provisions and Eligibility<\/h3>\n\t<div id=\"gap-1345911776\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1345911776 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>To qualify for <strong>priority review<\/strong>, ANDA applicants must fulfill <strong>all three<\/strong> of the following criteria:<\/p>\n<ol>\n<li>Conduct or obtain a waiver for <strong>bioequivalence testing<\/strong> in the U.S.<\/li>\n<li><strong>Manufacture finished dosage forms<\/strong><\/li>\n<li>Use <strong>API suppliers located in the U.S. <\/strong><a href=\"https:\/\/natlawreview.com\/article\/fda-launches-new-anda-prioritization-pilot-support-us-based-generic-manufacturing\"><strong><sup>[1]<\/sup><\/strong><\/a><\/li>\n<\/ol>\n<p>Applicants must reference <a href=\"https:\/\/www.fda.gov\/media\/89061\/download#:~:text=This%20MAPP%20describes%20how%20the%20review%20of%20original,Original%20ANDAs%2C%20Amendments%2C%20and%20Supplements%20%28January%2030%2C%202020%29.\"><strong>FDA\u2019s Manual of Policies and Procedures (MAPP) 5240.3<\/strong><\/a> when requesting prioritization under this pilot program. The program is open-ended, with <strong>no specified deadline<\/strong> for participation, allowing ongoing submissions under this framework.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-580100225 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-766243967\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Why It Matters<\/h3>\n\t<div id=\"gap-1664828449\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1664828449 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>The pilot program represents a <strong>strategic shift toward onshoring critical pharmaceutical operations<\/strong>. With <strong>over 50% of pharmaceuticals distributed in the U.S. manufactured overseas<\/strong> and only <strong>9% of API manufacturers based domestically<\/strong>, <a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025\"><sup>[2]<\/sup><\/a> this initiative supports <strong>supply chain security<\/strong>, <strong>faster market access for generics<\/strong>, and <strong>enhanced regulatory efficiency<\/strong>.<\/p>\n<p>By incentivizing local production and testing, the FDA aims to <strong>bolster public health infrastructure<\/strong>, <strong>stimulate domestic R&amp;D<\/strong>, and <strong>mitigate risks linked to international supply disruptions<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-766243967 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-11424960\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Who Should Take Note<\/h3>\n\t<div id=\"gap-168443784\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-168443784 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>This update is particularly relevant for <strong>regulatory affairs<\/strong>, <strong>quality assurance<\/strong>, and <strong>manufacturing operations teams<\/strong> within generic drug companies. Organizations preparing ANDA submissions should assess their <strong>manufacturing geography, testing practices, and supplier base<\/strong> to determine eligibility for the <strong>FDA\u2019s expedited review pathway<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-11424960 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-639612079\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h3>Next Steps<\/h3>\n\t<div id=\"gap-356910958\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-356910958 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Stakeholders are advised to:<\/p>\n<ul>\n<li>Review their manufacturing and testing workflows against the pilot\u2019s eligibility requirements.<\/li>\n<li>Reference <strong>MAPP 5240.3<\/strong> when submitting ANDAs to request prioritization.<\/li>\n<li>Maintain supporting documentation to demonstrate compliance with domestic sourcing and testing standards.<\/li>\n<\/ul>\n<p>For teams navigating regulatory submissions or preparing for shifting U.S. compliance frameworks, leveraging predictive and automated intelligence tools can ensure timely action and submission accuracy.<\/p>\n<p><a href=\"https:\/\/regask.com\/\"><strong>RegASK<\/strong><\/a> is a leading <strong>agentic AI regulatory intelligence and workflow orchestration platform<\/strong> that empowers global organizations in <strong>highly regulated sectors<\/strong>, including <strong>life sciences and consumer goods<\/strong>, to proactively navigate complex regulatory landscapes. By leveraging <strong>experts in the loop<\/strong>, RegASK delivers <strong>predictive actionable insights<\/strong>, <strong>end-to-end automation<\/strong>, and <strong>real-time compliance tracking<\/strong> across <strong>140+ countries <\/strong>streamlining submissions like ANDAs and accelerating market access.<br \/>\n<a href=\"https:\/\/regask.com\/product\/\"><strong>Learn more<\/strong><\/a><strong> or <\/strong><a href=\"https:\/\/regask.com\/book-a-demo\/\"><strong>book a demo now.<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-639612079 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1554231589\">\n\n\t<div id=\"col-213713082\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQs<\/h3>\n\t<div id=\"gap-1552225709\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1552225709 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>What is the FDA\u2019s new pilot program about?<\/h4>\n\t<div id=\"gap-2012527725\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2012527725 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>The program prioritizes review of ANDAs for generic drugs manufactured and tested in the U.S., aiming to strengthen domestic production and reduce reliance on foreign suppliers.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-213713082 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1773184503\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>What are the eligibility criteria for priority review?<\/h4>\n\t<div id=\"gap-400350080\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-400350080 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>ANDA applicants must conduct bioequivalence testing in the U.S., manufacture finished dosage forms domestically, and source APIs exclusively from U.S.-based suppliers.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1773184503 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-625483519\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Is there a submission deadline for this pilot program?<\/h4>\n\t<div id=\"gap-209063359\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-209063359 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>No, the FDA has not specified a deadline. Eligible ANDAs can be submitted on an ongoing basis under the pilot framework.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-625483519 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2091412683\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>How can RegASK support organizations with this FDA initiative?<\/h4>\n\t<div id=\"gap-2145998710\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2145998710 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"https:\/\/regask.com\/\">RegASK<\/a> Helps manufacturers and compliance teams monitor evolving FDA policies, automate documentation workflows, and align submission strategies with programs like the FDA\u2019s prioritization pilot to ensure faster, compliant market entry.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2091412683 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1410843851\">\n\n\t<div id=\"col-1230429794\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>References<\/h3>\n\t<div id=\"gap-950500289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-950500289 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><a href=\"https:\/\/natlawreview.com\/article\/fda-launches-new-anda-prioritization-pilot-support-us-based-generic-manufacturing\">Natlawreview &#8211; FDA Launches New ANDA Prioritization Pilot to Support U.S.-Based Generic Manufacturing<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/drugs\/news-events-human-drugs\/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025\">gov &#8211; FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products<\/a><\/li>\n<\/ol>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1230429794 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u56fd\u5185\u3067\u306e\u88fd\u9020\u3068\u8a66\u9a13\u3092\u652f\u63f4\u3059\u308b\u7c21\u6613\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\uff08ANDA\uff09\u306e\u512a\u5148\u5be9\u67fb\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u30022025\u5e7410\u67083\u65e5\u306b\u958b\u59cb\u3055\u308c\u305f\u3053\u306e\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u7533\u8acb\u306e\u5be9\u67fb\u671f\u9593\u3092\u77ed\u7e2e\u3057\u3001\u6d77\u5916\u3078\u306e\u4f9d\u5b58\u5ea6\u3092\u6e1b\u3089\u3057\u3001\u7c73\u56fd\u306e\u533b\u85ac\u54c1\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u56de\u5fa9\u529b\u3092\u9ad8\u3081\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u306f\u3001\u7c73\u56fd\u5185\u3067\u751f\u7269\u5b66\u7684\u540c\u7b49\u6027\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u56fd\u5185\u3067\u6700\u7d42\u88fd\u5264\u3092\u88fd\u9020\u3057\u3001\u6709\u52b9\u533b\u85ac\u54c1\u6210\u5206\uff08API\uff09\u3092\u7c73\u56fd\u5185\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u306e\u307f\u8abf\u9054\u3059\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u304c\u512a\u5148\u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u63aa\u7f6e\u306f\u3001\u56fd\u5185\u306e\u7814\u7a76\u958b\u767a\u80fd\u529b\u3092\u5f37\u5316\u3057\u3001\u691c\u67fb\u30b3\u30b9\u30c8\u3068\u9045\u5ef6\u3092\u524a\u6e1b\u3059\u308b\u3053\u3068\u3067\u3001\u516c\u8846\u885b\u751f\u3068\u56fd\u5bb6\u5b89\u5168\u4fdd\u969c\u306e\u4e21\u65b9\u306e\u30ea\u30b9\u30af\u306b\u5bfe\u51e6\u3057\u307e\u3059\u3002<\/p>","protected":false},"author":32,"featured_media":8794,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33],"tags":[],"class_list":["post-8793","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>New FDA Pilot Program to Transform Drug Manufacturing<\/title>\n<meta name=\"description\" content=\"Explore the New FDA Pilot Program that could reshape the future of U.S. generic drug manufacturing and enhance supply chains.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/\u7c73\u56fd\u306e\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u88fd\u9020\u306e\u672a\u6765\u3092\u5909\u3048\u308b\u53ef\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New FDA Pilot Program that Could Reshape the Future of U.S. Generic Drug Manufacturing\" \/>\n<meta property=\"og:description\" content=\"Explore the New 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