{"id":58012,"date":"2026-02-26T16:06:32","date_gmt":"2026-02-26T08:06:32","guid":{"rendered":"https:\/\/flcube.com\/?p=58012"},"modified":"2026-02-26T16:06:33","modified_gmt":"2026-02-26T08:06:33","slug":"nmpa-cde-opens-public-consultation-for-104th-reference-listed-drugs-catalog-63-specifications-under-review","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58012","title":{"rendered":"NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog \u2013 63 Specifications Under Review"},"content":{"rendered":"\n<p>The <strong>Center for Drug Evaluation (CDE)<\/strong> of China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> officially opened a <strong>public consultation<\/strong> for the <strong>104th Batch<\/strong> of the <strong>&#8220;Reference Listed Drugs (RLD) Catalog for Chemical Generics.&#8221;<\/strong> The draft catalog includes <strong>63 total specifications<\/strong> under review, comprising <strong>15 newly added<\/strong>, <strong>32 supplemented<\/strong>, and <strong>16 failed evaluations<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-update\">Regulatory Update<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Regulatory Body<\/strong><\/td><td>Center for Drug Evaluation (CDE), NMPA<\/td><\/tr><tr><td><strong>Document<\/strong><\/td><td>104th Batch Reference Listed Drugs (RLD) Catalog<\/td><\/tr><tr><td><strong>Action<\/strong><\/td><td>Public consultation opened<\/td><\/tr><tr><td><strong>Consultation Type<\/strong><\/td><td>Draft catalog for chemical generics reference standards<\/td><\/tr><tr><td><strong>Total Specifications<\/strong><\/td><td><strong>63<\/strong><\/td><\/tr><tr><td>\u2014 Newly Added<\/td><td><strong>15<\/strong><\/td><\/tr><tr><td>\u2014 Supplemented<\/td><td><strong>32<\/strong><\/td><\/tr><tr><td>\u2014 Failed Evaluation<\/td><td><strong>16<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-rld-catalog-significance\">RLD Catalog Significance<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Function<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>Bioequivalence Standard<\/strong><\/td><td>Defines reference products for generic drug development and approval<\/td><\/tr><tr><td><strong>Quality Benchmark<\/strong><\/td><td>Ensures chemical generics meet innovator product standards<\/td><\/tr><tr><td><strong>Market Access<\/strong><\/td><td>Inclusion enables generic developers to proceed with bioequivalence studies<\/td><\/tr><tr><td><strong>Regulatory Clarity<\/strong><\/td><td>Failed evaluations provide guidance on non\u2011viable reference pathways<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications\">Strategic Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Generic Development Guidance:<\/strong> The <strong>104th batch update<\/strong> provides critical reference standards for domestic and multinational generic manufacturers seeking <strong>NMPA approval<\/strong> for chemical generics in China.<\/li>\n\n\n\n<li><strong>Portfolio Planning:<\/strong> <strong>15 newly added specifications<\/strong> represent new generic opportunities; <strong>32 supplemented entries<\/strong> clarify existing standards; <strong>16 failures<\/strong> signal regulatory expectations for bioequivalence feasibility.<\/li>\n\n\n\n<li><strong>International Harmonization:<\/strong> RLD catalog alignment with <strong>FDA Reference Listed Drugs<\/strong> and <strong>EMA reference products<\/strong> supports global generic development strategies and mutual recognition pathways.<\/li>\n\n\n\n<li><strong>Market Competition:<\/strong> Expanded RLD catalog enables <strong>greater generic competition<\/strong>, potentially accelerating price reductions and improving access to essential medicines in China&#8217;s healthcare system.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-industry-impact\">Industry Impact<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Stakeholder<\/th><th>Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>Domestic Generic Manufacturers<\/strong><\/td><td>New reference standards enable pipeline expansion; failed evaluations prevent resource misallocation<\/td><\/tr><tr><td><strong>Multinational Pharma<\/strong><\/td><td>RLD updates inform lifecycle management and patent strategy for innovator products approaching expiry<\/td><\/tr><tr><td><strong>Regulatory Consultants<\/strong><\/td><td>60\u2011day consultation period provides opportunity for stakeholder input on contested specifications<\/td><\/tr><tr><td><strong>Healthcare System<\/strong><\/td><td>Broader generic availability supports national drug procurement and reimbursement cost containment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding final catalog publication, generic approval timelines, and market access implications. Actual results may differ due to risks including consultation feedback revisions, regulatory policy changes, and bioequivalence study complexity.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Center for Drug Evaluation (CDE) of China&#8217;s National Medical Products Administration (NMPA) officially opened&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[4],"tags":[102],"class_list":["post-58012","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-cde"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog \u2013 63 Specifications Under Review - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) of China&#039;s National Medical Products Administration (NMPA) officially opened a public consultation for the 104th Batch of the &quot;Reference Listed Drugs (RLD) Catalog for Chemical Generics.&quot; The draft catalog includes 63 total specifications under review, comprising 15 newly added, 32 supplemented, and 16 failed evaluations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=58012\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog \u2013 63 Specifications Under Review\" \/>\n<meta property=\"og:description\" content=\"The Center for Drug Evaluation (CDE) of China&#039;s National Medical Products Administration (NMPA) officially opened a public consultation for the 104th Batch of the &quot;Reference Listed Drugs (RLD) Catalog for Chemical Generics.&quot; The draft catalog includes 63 total specifications under review, comprising 15 newly added, 32 supplemented, and 16 failed evaluations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=58012\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-26T08:06:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-26T08:06:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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