{"id":41082,"date":"2025-09-10T15:53:50","date_gmt":"2025-09-10T07:53:50","guid":{"rendered":"https:\/\/flcube.com\/?p=41082"},"modified":"2025-09-10T15:53:51","modified_gmt":"2025-09-10T07:53:51","slug":"chinas-11th-national-drug-vbp-draft-unveils-major-pricing-competition-reforms","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=41082","title":{"rendered":"China\u2019s 11th National Drug VBP Draft Unveils Major Pricing &amp; Competition Reforms"},"content":{"rendered":"\n<p>The second\u2011draft rules for China\u2019s 11th round of national centralized drug procurement (<strong>VBP 11th<\/strong>) have been released online, introducing sweeping changes to the competitive landscape, pricing methodology, and procurement cycle. The revisions aim to tighten market discipline, foster fair competition, and ensure value\u2011based access to essential medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-1-competitive-landscape-adjustments\">1. Competitive Landscape Adjustments<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>New Requirement<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Number of Competitors<\/strong><\/td><td>Seven companies (including reference\u2011listed drugs and those that passed quality\u2011consistency evaluation) must compete for each product.<\/td><\/tr><tr><td><strong>Exclusions<\/strong><\/td><td>\u2022 Products still under a medical\u2011insurance negotiation or &lt;\u202f1\u202fyr after win.<br>\u2022 Products with &lt;\u202f100\u202fmillion\u202fRMB procurement on provincial platforms (2024).<br>\u2022 Products flagged as high\u2011risk clinically or for patent infringement.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-relaxed-company-application-criteria\">2. Relaxed Company Application Criteria<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Old rule<\/strong>: One market\u2011sales certificate, \u2265\u202f2\u202fyrs within the last 3\u202fyrs.<\/li>\n\n\n\n<li><strong>New rule<\/strong>: Two market\u2011sales certificates, \u2265\u202f2\u202fyrs within the last <strong>5<\/strong>\u202fyrs (Sept\u202f2020\u202f\u2013\u202fSept\u202f2025).<\/li>\n<\/ul>\n\n\n\n<p>This broadens the pool of eligible manufacturers while maintaining a minimum sales track record.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-procurement-cycle-amp-pricing-framework\">3. Procurement Cycle &amp; Pricing Framework<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Old (Rounds\u202f1\u20112)<\/th><th>New (Round\u202f11)<\/th><\/tr><\/thead><tbody><tr><td><strong>Cycle length<\/strong><\/td><td>4\u202fyears<\/td><td>~3\u202fyears (till\u202f31\u202fDec\u202f2028)<\/td><\/tr><tr><td><strong>Highest valid bid price<\/strong><\/td><td>Not specified<\/td><td>Lower of:<br>\u2022 50\u202f% of weighted\u2011average price of non\u2011centralized online listings<br>\u2022 Highest winning bid in provincial centralized procurement<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>International prices and online pharmacy rates are now factored into the calculation.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-bid-based-shortlisting-amp-price-spread-controls\">4. Bid\u2011Based Shortlisting &amp; Price\u2011Spread Controls<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Shortlisting rule<\/strong>: Reverts to the 10th\u2011round model to keep overall shortlisting rate stable.<\/li>\n\n\n\n<li><strong>Anchor point for price spread<\/strong>: Higher of 50\u202f% of the average shortlisted price <strong>or<\/strong> the lowest bid price.<\/li>\n\n\n\n<li><strong>Price\u2011spread circuit breaker<\/strong>: Triggered if a bid exceeds <strong>1.8\u202f\u00d7\u202fanchor point<\/strong> (exempt for low\u2011priced oral solids \u2264\u202f0.1\u202fRMB, small\u2011volume injections \u2264\u202f1\u202fRMB, large\u2011volume injections \u2264\u202f2\u202fRMB).<\/li>\n<\/ul>\n\n\n\n<p>If a company is short\u2011listed but hits the breaker, it can be <em>revived<\/em> by dropping its bid to the highest non\u2011breaker bid. The revival price equals 1.8\u202f\u00d7\u202fanchor point if only one company triggers the breaker.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-volume-based-procurement-amp-market-share-caps\">5. Volume\u2011Based Procurement &amp; Market\u2011Share Caps<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Designation<\/strong>: Short\u2011listed (direct or revived) companies become suppliers for institutions that report demand for their specific brand.<\/li>\n\n\n\n<li><strong>Agreed volume<\/strong>: ~80\u202f% of the institution\u2019s reported volume.<\/li>\n\n\n\n<li><strong>Single\u2011company cap<\/strong>: If a company\u2019s cumulative agreed volume reaches 50\u202f% of total reported volume for a product, each institution\u2019s volume is capped at 50\u202f% of its reported amount. This portion is not counted toward the agreed volume and can be sourced independently.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-6-penalties-for-non-compliance\">6. Penalties for Non\u2011Compliance<\/h2>\n\n\n\n<p>Companies added to the non\u2011compliance list face disqualification from all NCDP bids and a ban from participating in national centralized procurement for <strong>6\u202fmonths to 5\u202fyears<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-7-implications-for-stakeholders\">7. Implications for Stakeholders<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Stakeholder<\/th><th>What to Expect<\/th><\/tr><\/thead><tbody><tr><td><strong>Manufacturers<\/strong><\/td><td>More competitors, tighter pricing, but relaxed entry criteria.<\/td><\/tr><tr><td><strong>Hospitals<\/strong><\/td><td>Potentially more reliable supply, but must navigate volume caps.<\/td><\/tr><tr><td><strong>Patients<\/strong><\/td><td>Anticipated cost savings from lower bid prices, but watch for supply gaps if volume caps trigger.<\/td><\/tr><tr><td><strong>Regulators<\/strong><\/td><td>Greater enforcement of compliance and market discipline.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Key Takeaways<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The 11th\u2011round rules tighten pricing, expand competition, and extend the procurement cycle.<\/li>\n\n\n\n<li>New mechanisms such as the price\u2011spread circuit breaker and revival options aim to prevent market distortions.<\/li>\n\n\n\n<li>Volume caps safeguard against monopolistic practices while ensuring hospitals can meet demand.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The second\u2011draft rules for China\u2019s 11th round of national centralized drug procurement (VBP 11th) have&#8230;<\/p>\n","protected":false},"author":1,"featured_media":41084,"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":[1],"tags":[],"class_list":["post-41082","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"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\u2019s 11th National Drug VBP Draft Unveils Major Pricing &amp; Competition Reforms - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The second\u2011draft rules for China\u2019s 11th round of national centralized drug procurement (VBP) have been released online, introducing sweeping changes to the competitive landscape, pricing methodology, and procurement cycle. 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