{"id":41768,"date":"2025-09-18T14:25:05","date_gmt":"2025-09-18T06:25:05","guid":{"rendered":"https:\/\/flcube.com\/?p=41768"},"modified":"2025-09-18T14:25:05","modified_gmt":"2025-09-18T06:25:05","slug":"china-cde-seeks-public-feedback-on-98th-batch-of-reference-standards-for-generic-drugs","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41768","title":{"rendered":"China\u202fCDE Seeks Public Feedback on 98th Batch of Reference Standards for Generic Drugs"},"content":{"rendered":"\n<p>The <strong>China Center for Drug Evaluation (CDE)<\/strong> has published a draft list of the 98th batch of reference standards for chemical generic drugs and is now calling for public comments. The move is part of CDE\u2019s ongoing effort to streamline the approval process for generic medicines while ensuring quality and safety.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-draft-list-highlights\">Draft List Highlights<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>21 new drug specifications<\/strong> \u2013 Standards for drugs that have not been previously released.<\/li>\n\n\n\n<li><strong>38 supplemental specifications<\/strong> \u2013 Updated information for drugs already on the market.<\/li>\n\n\n\n<li><strong>9 failed\u2011review specifications<\/strong> \u2013 Entries that did not meet the required criteria and are awaiting revision.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-why-it-matters\">Why It Matters<\/h4>\n\n\n\n<p>Reference standards serve as the benchmark for quality control in the manufacturing of generic drugs. By opening the 98th batch for public scrutiny, CDE aims to gather input from industry stakeholders, academia, and the broader public, potentially accelerating the availability of affordable, high\u2011quality generics across China.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-public-consultation-window\">Public Consultation Window<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Submission period<\/strong>: July\u202f18\u202f\u2013\u202fAugust\u202f18,\u202f2025.<\/li>\n\n\n\n<li><strong>How to comment<\/strong>: Stakeholders can submit written comments through the CDE\u2019s online portal or by email.<\/li>\n\n\n\n<li><strong>Next steps<\/strong>: CDE will review all feedback, make necessary revisions, and finalize the standards by early 2026.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-industry-implications\">Industry Implications<\/h4>\n\n\n\n<p>The inclusion of 21 new specifications signals a continued push toward expanding the generic drug portfolio, while the 9 failed reviews underscore the CDE\u2019s commitment to rigorous quality control. Companies that rely on these standards for production will need to monitor revisions closely to ensure compliance and avoid potential delays in market entry.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The China Center for Drug Evaluation (CDE) has published a draft list of the 98th&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41777,"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":[11,4],"tags":[102,103,14],"class_list":["post-41768","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug","category-policy-regulatory","tag-cde","tag-gqce-testing","tag-nmpa"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>China\u202fCDE Seeks Public Feedback on 98th Batch of Reference Standards for Generic Drugs - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China Center for Drug Evaluation (CDE) has published a draft list of the 98th batch of reference standards for chemical generic drugs and is now calling for public comments. 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