{"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":"fda-%e7%9a%84%e6%96%b0%e8%af%95%e7%82%b9%e9%a1%b9%e7%9b%ae%e6%88%96%e5%b0%86%e9%87%8d%e5%a1%91%e7%be%8e%e5%9b%bd%e4%bb%bf%e5%88%b6%e8%8d%af%e5%88%b6%e9%80%a0%e4%b8%9a%e7%9a%84%e6%9c%aa%e6%9d%a5","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/new-fda-pilot-program-that-could-reshape-the-future-of-u-s-generic-drug-manufacturing\/","title":{"rendered":"FDA \u7684\u65b0\u8bd5\u70b9\u8ba1\u5212\u53ef\u80fd\u4f1a\u91cd\u5851\u2026\u2026\u7684\u672a\u6765"},"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-2051775331\">\n\n\t<div id=\"col-1225267360\" 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-834823289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-834823289 {\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-1225267360 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1534759711\" 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-509498964\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-509498964 {\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-1534759711 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-81671640\" 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-1818735\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1818735 {\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-81671640 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2116760662\" 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-1433780412\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1433780412 {\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-2116760662 > .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-1320245069\">\n\n\t<div id=\"col-289574520\" 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-2146630649\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2146630649 {\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-1057498496\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1057498496 {\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-289574520 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-615395080\" 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-2092528461\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2092528461 {\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-615395080 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1118688431\" 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-897614621\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-897614621 {\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-1118688431 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1458075416\" 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-1432318131\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1432318131 {\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-1458075416 > .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-1036835240\">\n\n\t<div id=\"col-477718974\" 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-1073047954\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1073047954 {\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-477718974 > .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>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA) \u5ba3\u5e03\u4e86\u4e00\u9879\u7b80\u5316\u65b0\u836f\u7533\u8bf7 (ANDA) \u8bd5\u70b9\u4f18\u5148\u9879\u76ee\uff0c\u65e8\u5728\u652f\u6301\u7f8e\u56fd\u56fd\u5185\u751f\u4ea7\u548c\u6d4b\u8bd5\u3002\u8be5\u9879\u76ee\u4e8e 2025 \u5e74 10 \u6708 3 \u65e5\u542f\u52a8\uff0c\u65e8\u5728\u52a0\u5feb\u5408\u683c\u7533\u8bf7\u7684\u5ba1\u67e5\u65f6\u95f4\uff0c\u51cf\u5c11\u5bf9\u5916\u56fd\u7684\u4f9d\u8d56\uff0c\u5e76\u589e\u5f3a\u7f8e\u56fd\u533b\u836f\u4f9b\u5e94\u94fe\u7684\u97e7\u6027\u3002\u6839\u636e\u2026\u2026<\/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 v28.0 (Yoast SEO v28.1) - 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 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