(VBP) bidder application meeting from October 21 to October 27. This year’s bidding process allows selected suppliers to directly deliver drug demand by brand, an approach adopted by over 77% of 46,000 institutions. Since its launch in 2018, the VBP program has cut average drug prices by 50% and now covers 55 drug varieties, with safeguards in place to prevent below-cost bidding and ensure fairness and quality. https://lnkd.in/dvi667AG #NAVLINDaily #PharmaPolicy #APAC
VBP bidder application meeting: Direct drug delivery by brand
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📌 Are compounded GLP-1 drugs getting crushed by regulatory uncertainty in Kentucky? One board draws a hard line, another offers exceptions—and providers are left in a bind. Get all the details and implications for practice in this in-depth analysis: 🔗 Read more → Kentucky’s Conflicting Signals on Compounded GLP-1s . https://lnkd.in/eZn56uai #pharmacylaw #healthpolicy #providerrisks #compoundeddrugs #legalinsight #floridahealthcarelaw #attorneyfeature #legalsupport #healthcareindustry #trustedadvisor #healthcarelaw #fhlf
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𝗔𝗿𝗲 𝘆𝗼𝘂 𝗰𝗼𝗻𝗳𝗶𝗱𝗲𝗻𝘁 𝘁𝗵𝗮𝘁 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗮𝗿𝗮𝘁𝗼𝗿 𝘀𝗼𝘂𝗿𝗰𝗶𝗻𝗴 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗰𝗮𝗻 𝘄𝗶𝘁𝗵𝘀𝘁𝗮𝗻𝗱 𝗮𝗻 𝗙𝗗𝗔 𝗮𝘂𝗱𝗶𝘁? With the 𝗗𝗦𝗖𝗦𝗔 𝗲𝗻𝗳𝗼𝗿𝗰𝗲𝗺𝗲𝗻𝘁 𝗱𝗲𝗮𝗱𝗹𝗶𝗻𝗲 𝗻𝗼𝘄 𝗶𝗻 𝗲𝗳𝗳𝗲𝗰𝘁 (𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟳, 𝟮𝟬𝟮𝟱), compliance is no longer a choice; it’s the law. The authenticity and traceability of comparator drugs can make or break your clinical trial journey. Many sourcing companies still rely on 𝗻𝗼𝗻-𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗰𝗵𝗮𝗻𝗻𝗲𝗹𝘀 because it’s cheaper than buying directly from legitimate WDLs. While this may save costs in the short term, it can become a 𝗺𝗮𝗷𝗼𝗿 𝗿𝗼𝗮𝗱𝗯𝗹𝗼𝗰𝗸 if your trial fails an FDA audit, setting progress back to zero. At 𝗦𝗽𝗿𝗶𝗻𝗴 𝗕𝗶𝗼 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻, we ensure comparator drugs are procured directly from 𝘃𝗲𝗿𝗶𝗳𝗶𝗲𝗱 𝘀𝗼𝘂𝗿𝗰𝗶𝗻𝗴 𝗰𝗵𝗮𝗻𝗻𝗲𝗹𝘀, safeguarding both compliance and patient safety. Together with our partner LSPedia, we also provide advanced serialization services to give you complete supply chain confidence. Stay ahead in the clinical trial game: https://lnkd.in/dgju6TTy See the FDA’s official update on DSCSA enforcement: https://lnkd.in/gNs348C #DSCSA #Compliance #ComparatorSourcing #Serialization #SpringBioSolution
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ICYMI: In last week’s House Committee on Energy and Commerce hearing, lawmakers highlighted the importance of promoting competition – cracking down on anti-competitive tactics used by Big Pharma to extend exclusivity that keeps drug prices HIGH. Hear what they had to say on the issue: https://lnkd.in/dgdSRUiN
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Strong MAH management is central to sustaining regulatory compliance and product trust. DDReg provides specialized MAH services that align global companies with local regulatory requirements, ensuring product continuity, vigilance, and compliance across markets. Discover more: https://lnkd.in/gAHP6Qge #RegulatoryExcellence #MAH #DDReg #PharmaQuality #RegulatoryAffairs #GlobalCompliance #Pharma #DDReg
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New Blog 💡 EMA Approval Timelines – How Long Does it Take From Positive CHMP Opinion to EC Decision? Regulatory timing matters. To support launch and access planning, we took a closer look at one key milestone in the EU approval process: the time between CHMP opinion and the final EC decision. Malte Glüsen, Senior Research Analyst found that the time between CHMP opinion and EC decision has remained remarkably stable, providing a reliable benchmark for regulatory and cross-functional planning. Understanding this timing helps teams anticipate launch readiness and coordinate market access activities with greater precision and confidence. Read the full blog to find out more: https://lnkd.in/eeTmQiEk #LifeScience #HealthEconomics #Pharma #DrugApproval #MarketAccess #EMA #CHMP #Kintiga
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When the White House announced the Strategic API Reserve, many saw it as a new initiative. At Callan JMB, we saw validation of decades of preparation. Long before the term ‘API Reserve’ was coined, we recognized the fragility of U.S. pharmaceutical supply chains. Through partnerships in Asia, expertise in logistics, and a relentless focus on secure infrastructure, we have positioned ourselves to deliver exactly what this mandate requires. For us, this isn’t about pivoting into a new space — it’s about stepping into a role we’ve been preparing to fill for years. Reducing dependence on foreign APIs is not just a matter of policy; it is a matter of national security. And we are ready. https://lnkd.in/gMZz23w9 #CallanJMB #WhiteHouseAPI #APIReserve
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British Pharmacopoeia 2026 – Key Highlights The BP 2026 brings new standards, sustainability, and digital innovation! 🔹 19 new monographs & 100+ revisions 🔹 BPCRS: 11 new reference substances 🔹 Scaled chromatographic methods to reduce solvent use 🔹 Guidance on ATMPs, AQbD & Sustainability 🔹 Integrates Ph. Eur. 12.3 for complete coverage 📅 Publishing on 1 August 2025 🔗 Learn more: https://lnkd.in/dXyBVewg #BritishPharmacopoeia #BP2026 #Pharma #QualityStandards #Gcc #Sfda #RegulatoryAffairs #Sustainability #MHRA
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Experts warn that weight-loss patches claiming to offer benefits similar to GLP-1 drugs lack FDA approval. Residents in Connecticut are advised to exercise caution, as these products may not be safe or effective, highlighting the importance of consulting healthcare professionals before use. Full story at the link below: https://lnkd.in/dumaXHsi #WeightLoss #HealthCaution #GLP1Drugs #Connecticut #FDAApproval
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The FDA just made 9 stocks jump 7-19% They awarded the first Commissioner's Vouchers On October 16, 2025, the FDA awarded the first 9 Commissioner's National Priority Vouchers This reduces review times from 10-12 months to just 1-2 months. 2 of the 9 vouchers (GSK Augmentin XR and Ketamine) were explicitly awarded for DOMESTIC MANUFACTURING. Where we manufacture may be worth $500M-$1B in faster market entry. Being in the US is now a much larger strategic advantage
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Following the #inauguration of its first US manufacturing site in Cranbury, New Jersey, in September, Biocon has announced that the facility, aimed at enhancing capacity and supply chain efficiency in the region, recently underwent a Good Manufacturing Practice #GMP inspection by the US FDA. Read more: https://lnkd.in/deXkikn5 #Cranbury #PharmaManufacturing #Biocon #GMP #GlobalHealthCare #PharmaIndustrialIssue
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