{"id":76469,"date":"2026-08-25T11:57:02","date_gmt":"2026-08-25T03:57:02","guid":{"rendered":"https:\/\/flcube.com\/?p=76469"},"modified":"2026-08-25T11:57:04","modified_gmt":"2026-08-25T03:57:04","slug":"nmpa-issues-108th-batch-catalog-of-reference-listed-drugs-for-generic-drugs-adding-17-new-specifications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=76469","title":{"rendered":"NMPA Issues 108th Batch Catalog of Reference Listed Drugs for Generic Drugs, Adding 17 New Specifications"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> issued the <strong>Catalog of Reference Listed Drugs for Generic Drugs (108th Batch)<\/strong> on Aug. 24, 2026. The latest release <strong>adds 17 new drug specifications<\/strong> to the catalog and provides <strong>supplementary updates for 28 specifications<\/strong> from previous batches, further refining the reference standards that govern generic drug development in China.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/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>Agency<\/strong><\/td><td>National Medical Products Administration (NMPA), China<\/td><\/tr><tr><td><strong>Document<\/strong><\/td><td>Catalog of Reference Listed Drugs for Generic Drugs<\/td><\/tr><tr><td><strong>Batch<\/strong><\/td><td>108th Batch<\/td><\/tr><tr><td><strong>New Specifications Added<\/strong><\/td><td>17<\/td><\/tr><tr><td><strong>Supplementary Updates<\/strong><\/td><td>28 specifications from prior batches<\/td><\/tr><tr><td><strong>Issue Date<\/strong><\/td><td>24 Aug 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-catalog-significance\" class=\"wp-block-heading\">Catalog Significance<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Reference Listed Drugs (RLDs):<\/strong> The catalog designates the originator or benchmark products against which Chinese generic applicants must demonstrate bioequivalence and quality consistency.<\/li>\n\n\n\n<li><strong>Expanding Scope:<\/strong> The addition of <strong>17 new specifications<\/strong> broadens the range of eligible reference products, signaling continued regulatory effort to align China&#8217;s generic approval framework with international standards.<\/li>\n\n\n\n<li><strong>Supplementary Updates:<\/strong> The <strong>28 updated entries<\/strong> from earlier batches typically reflect refined technical specifications, sourcing information or administrative corrections that help streamline generic development programs.<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-industry-implications\" class=\"wp-block-heading\">Industry Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>For Generic Developers:<\/strong> Newly listed RLDs clarify development pathways for additional products, reducing uncertainty for companies planning bioequivalence studies and Abbreviated New Drug Applications in China.<\/li>\n\n\n\n<li><strong>For Market Competition:<\/strong> An expanded and updated catalog supports faster entry of quality generics, which can intensify price competition and improve patient access to essential therapies.<\/li>\n\n\n\n<li><strong>Regulatory Trajectory:<\/strong> The NMPA continues its steady cadence of catalog releases as part of a broader reform agenda aimed at raising generic quality and accelerating drug availability in the world&#8217;s second\u2011largest pharmaceutical market.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding the implications of the 108th Batch catalog for generic drug development and market dynamics in China. Actual outcomes may differ due to regulatory developments, approval timelines and competitive factors.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s National Medical Products Administration (NMPA) issued the Catalog of Reference Listed Drugs for Generic&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[4],"tags":[103],"class_list":["post-76469","post","type-post","status-publish","format-standard","hentry","category-policy-regulatory","tag-gqce-testing"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NMPA Issues 108th Batch Catalog of Reference Listed Drugs for Generic Drugs, Adding 17 New Specifications - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s National Medical Products Administration (NMPA) issued the Catalog of Reference Listed Drugs for Generic Drugs (108th Batch) on Aug. 24, 2026. The latest release adds 17 new drug specifications to the catalog and provides supplementary updates for 28 specifications from previous batches, further refining the reference standards that govern generic drug development in China.\" \/>\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=76469\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NMPA Issues 108th Batch Catalog of Reference Listed Drugs for Generic Drugs, Adding 17 New Specifications\" \/>\n<meta property=\"og:description\" content=\"China&#039;s National Medical Products Administration (NMPA) issued the Catalog of Reference Listed Drugs for Generic Drugs (108th Batch) on Aug. 24, 2026. 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