{"id":45886,"date":"2025-11-05T15:42:19","date_gmt":"2025-11-05T07:42:19","guid":{"rendered":"https:\/\/flcube.com\/?p=45886"},"modified":"2025-11-05T15:42:20","modified_gmt":"2025-11-05T07:42:20","slug":"china-cde-opens-public-comment-on-100th-batch-of-reference-standards-for-chemical-generic-drugs","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45886","title":{"rendered":"China CDE Opens Public Comment on 100th Batch of Reference Standards for Chemical Generic Drugs"},"content":{"rendered":"\n<p>The <strong>China Center for Drug Evaluation (CDE)<\/strong> has released a <strong>draft list of the 100th batch of reference standards<\/strong> for chemical generic medicines and is now seeking comments from industry stakeholders, academia, and the public. The notice, posted on <strong>4\u202fNov\u202f2025<\/strong>, outlines <strong>73 individual specifications<\/strong> and invites feedback through the CDE\u2019s online portal until <strong>30\u202fNov\u202f2025<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-composition-of-the-draft-list\">Composition of the Draft List<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Category<\/th><th>Number of Specifications<\/th><th>Description<\/th><\/tr><\/thead><tbody><tr><td><strong>Newly Introduced Standards<\/strong><\/td><td><strong>38<\/strong><\/td><td>Drug specifications that have never been published before.<\/td><\/tr><tr><td><strong>Supplementary Updates<\/strong><\/td><td><strong>18<\/strong><\/td><td>Additional data or clarifications for drugs that already have published standards.<\/td><\/tr><tr><td><strong>Failed Review<\/strong><\/td><td><strong>17<\/strong><\/td><td>Specifications that did not meet CDE\u2019s technical criteria and were rejected.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-why-the-100th-batch-matters\">Why the 100th Batch Matters<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Transparency<\/strong> \u2013 Publishing a comprehensive reference\u2011standard list supports <strong>quality\u2011by\u2011design<\/strong> and aligns Chinese generic drugs with international benchmarks (e.g., USP, EP).<\/li>\n\n\n\n<li><strong>Market Impact<\/strong> \u2013 Manufacturers must align their production processes with the approved standards to maintain <strong>registration eligibility<\/strong> and avoid supply\u2011chain disruptions.<\/li>\n\n\n\n<li><strong>Innovation Incentive<\/strong> \u2013 The 38 new specifications create entry points for <strong>R&amp;D investment<\/strong> in previously underserved therapeutic areas.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-how-to-submit-feedback\">How to Submit Feedback<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Access the Draft List<\/strong> \u2013 Visit the CDE website\u2019s \u201cReference Standards\u201d section (URL: <code>www.cde.org.cn\/reference2025<\/code>).<\/li>\n\n\n\n<li><strong>Register an Account<\/strong> \u2013 Provide organization details and contact information.<\/li>\n\n\n\n<li><strong>Upload Comments<\/strong> \u2013 Submit a PDF or Word document (max\u202f5\u202fMB) outlining technical objections, supporting data, or suggestions.<\/li>\n\n\n\n<li><strong>Deadline<\/strong> \u2013 All comments must be received by <strong>23:59\u202fBeijing Time on 30\u202fNov\u202f2025<\/strong>.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-potential-outcomes\">Potential Outcomes<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Standard Adoption<\/strong> \u2013 Accepted specifications become mandatory references for <strong>generic drug registration<\/strong> and <strong>post\u2011market surveillance<\/strong>.<\/li>\n\n\n\n<li><strong>Re\u2011evaluation<\/strong> \u2013 Rejected or partially accepted items may be <strong>re\u2011submitted<\/strong> in the next batch (101st) after additional data are provided.<\/li>\n\n\n\n<li><strong>Policy Adjustments<\/strong> \u2013 Feedback may prompt the CDE to refine its <strong>evaluation criteria<\/strong>, influencing future generic\u2011drug approval timelines.<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements concerning the impact of the 100th batch of reference standards on China\u2019s generic\u2011drug market. Actual results may differ due to regulatory changes, stakeholder responses, and market dynamics.<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 released a draft list of the 100th&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45887,"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":[102,103,14],"class_list":["post-45886","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","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 CDE Opens Public Comment on 100th Batch of Reference Standards for Chemical Generic Drugs - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The China Center for Drug Evaluation (CDE) has released a draft list of the 100th batch of reference standards for chemical generic medicines and is now seeking comments from industry stakeholders, academia, and the public. 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