US Pharmacopeia’s Post

🌍 Exciting News for Health & Pharmaceutical Industry Professionals! 🌍 The Pharma West Africa Conference is launching, shining a spotlight on the crucial topic of medicine supply in Nigeria. This new international event is a must-attend for anyone looking to make a difference in the health and pharmaceutical sectors. 📈 Discover innovative strategies, network with industry leaders, and be part of the conversation that's setting new standards in healthcare accessibility and quality. 🔍 Want to know more? Read the full case study and see how this conference is poised to transform the pharmaceutical landscape in West Africa. 👉 Read the full case study: https://lnkd.in/ebjAXGMc #PharmaWestAfrica #HealthcareInnovation #MedicineSupplyChain

𝐀𝐥𝐦𝐚𝐜 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐈𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭 𝐢𝐧 𝐒𝐢𝐧𝐠𝐚𝐩𝐨𝐫𝐞 𝐭𝐨 𝐄𝐧𝐡𝐚𝐧𝐜𝐞 𝐂𝐨𝐥𝐝 𝐂𝐡𝐚𝐢𝐧 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐟𝐨𝐫 𝐆𝐥𝐨𝐛𝐚𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐒𝐩𝐨𝐧𝐬𝐨𝐫𝐬 𝐚𝐧𝐝 𝐏𝐚𝐭𝐢𝐞𝐧𝐭𝐬 Almac Clinical Services is proud to announce a significant investment to enhance our frozen facility in Singapore! This expansion will quadruple the current floorspace and add 480 storage locations, boosting our capabilities to support global pharmaceutical sponsors. Our advanced facility, operating between -25°C to -15°C, includes a secondary production room, perfect for managing temperature-sensitive clinical supplies. This strategic move aligns with industry trends and the increasing demand for sophisticated cold chain solutions. Kevin Cheong Yan Foong, Director of Clinical Operations, states: "Our continuous improvements in biologics support ensure patients worldwide receive the highest quality care. This investment reflects our commitment to excellence and innovation." 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞: https://lnkd.in/g6kE9NQu 𝐒𝐭𝐚𝐲 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐨𝐧 𝐨𝐮𝐫 𝐥𝐚𝐭𝐞𝐬𝐭 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭𝐬:  https://lnkd.in/gkDAjWnN #AlmacClinicalServices #ColdChain #Pharmaceuticals #SingaporeExpansion #ClinicalSupplyChain #GlobalHealth #TemperatureControl #Biopharma #HealthcareInnovation #PatientCare #ClinicalResearch #SupplyChainManagement #Biotech #LifeSciences #SupplyWithCare

Reflecting on valuable information sharing between national trade associations This morning, I had the privilege of joining an insightful conversation and information sharing between industry experts from The Association of the British Pharmaceutical Industry (ABPI) and Danish Association of the Pharmaceutical Industry - Lif - Lægemiddelindustriforeningen The conversation focused on regulatory value and access policy environment for medicines in the UK and Denmark, sharing notes on current complexities, challenges and opportunities within the regulatory frameworks and the UK's appeal as a destination for life sciences investment. Key takeaways include the potential for regulatory improvements, the impact of international collaborations, and innovative pathways to market access for new medicines in both territories, underscoring the necessity of a patient-centric approach in developing regulatory systems for innovation in the pharmaceutical landscape Thanks to Daniel O'Connor, Orban Holdgate, Andy Collier, Louise Broe, Pernille Langgaard-Lauridsen, Thomas Klit Christensen and Joakim Steen Barron-Mikkelsen for a constructive and enlightening session. More of this please! #PharmaceuticalIndustry #RegulatoryAffairs #HealthTechnologyAssessment #InnovationInHealthcare #RegulatoryInnovation

One Year Later: The Impact of Kazakhstan's implementation of Strategically Important Medicines List On March 3, 2023, Kazakhstan approved a critical policy to ensure the registration of strategically important medicines, aiming to enhance healthcare resilience. As we are to mark a year since its implementation, I'm keen to understand its effects on the healthcare and pharmaceutical sectors. Discussion Points: 1)Registration Choices: Did you opt for registration through the List of Strategically Important Medicines or via EAEU regulation? What influenced your decision? 2)Experiences: What challenges and successes have you encountered under this policy? 3)Future Outlook: For those with marketing authorizations from this pathway, what prospects or hurdles do you foresee? I encourage professionals to share insights on the policy's market impact, helping us understand its effectiveness and potential lessons for Kazakhstani healthcare strategies.#drugregulatoryaffairskazakhstan #eaeu

Orphan medicines Pharma package provisions unleash uncertainties, stakeholders warn There are more than 6,000 rare diseases, with 27 different healthcare systems governed by conflicting rules and principles, with no harmonisation for orphan medicines payments. According to a study conducted by Dolon, the provisions relevant to orphan medicines proposed by the Commission as part of the revision of the pharmaceutical legislation would hamper the development of 45 products in Europe in 2020-2035. Natz points out that the proposed new legislation, which provides only one additional year of regulatory data protection for a new indication, forfeits the advantages gained from the existing orphan legislation, which grants a separate orphan market exclusivity period for every indication for different rare conditions. https://lnkd.in/dRJDsb-A #PublicHealth #Europe #StayInformed #StayEmpowered

"On both sides of the Atlantic, generic and biosimilar medicines play a critical role in enhancing patient access and healthcare sustainability, accounting for 70% of medicines prescribed in the EU and 90% of prescriptions filled in the US. Almost 77% of all prescriptions dispensed in Canada in 2023 were for generic medicines..." Industry experts with the Association for Accessible Medicines, Canadian Generic Pharmaceutical Association and Medicines for Europe have announced a new transatlantic partnership for the secure supply of medicines --- focusing on three essential areas of collaboration: 💊 Security of medicines supply  ⛑ Solidarity-based responses to crises 🌎 Bilateral and multilateral regulatory cooperation READ the full publication: https://lnkd.in/e459KH_a Biosimilars Council #generics #biosimilars #rx

It was my pleasure to speak at the Arab Pharmaceutical Industries Forum titled “Value Added Medicines, the way forward in Arab countries” which was in Amman on July 2&3. Value Added Medicines (VAM) address patients’ unmet needs through repurposing existing medicines. They represent an opportunity to manufacturers to differentiate specially in a highly competitive and protected markets. Collaboration with academia is a key to identify the needs, integrate and deliver solutions & improve heathcare outcomes. Overcoming the barriers including regulatory & pricing issues is essential to incentivise the research & facilitate the availability of VAM. #VAM value added medicines #safety #efficacy

European access to new medicines is a national postcode lottery Euractiv's cross-country report highlighted inequalities between member states regarding access to novel medicines the fragmented picture goes wider as indicated by the W.A.I.T. indicator - a European study into the availability of innovative medicines, conducted by IQVIA on behalf of the European Pharmaceutical Association. Improving access to medicines is a joint responsibility of industry and government, explained Ven, adding: "Today, important reforms are being worked out at both European and Belgian level to improve access to medicines on the one hand and to stimulate research and development towards innovation on the other." "We know that delays in patients' access to new medicines can occur even before a medicine has approval due to Europe's relatively slow regulatory processes," Nathalie Moll explained, adding that improving the European Medicines Agency's approval speed is a key ambition of the revision of the pharmaceutical legislation, as it is currently slower than the US and other parts of the world. https://lnkd.in/ev47uBXC #PublicHealth #Europe #StayInformed #StayEmpowered

Today the European Commission’s DG HERA (EU in Emergencies) launched the Critical Medicines Alliance (CMA). This is the “industrial policy” pillar of the EU strategy to tackle medicines shortages, alongside regulatory measures advanced via the revision of the EU pharmaceutical legislation. The CMA gathers 250+ stakeholders from public and private sector to jointly develop medium-term solutions. By the end of 2024, the Alliance will approve a Strategic Action Plan which at the moment focuses on 1) strengthening EU manufacturing capacity; and 2) Diversifying supply chains. The CMA follows the publication of the Union List of Critical Medicines by the EMA last year, with 216 medicines for now. As a member of the Alliance, Pfizer welcomes the opportunity to continue partnering with governments, EU institutions and relevant stakeholders to prevent and manage medicines shortages. We notably need to ensure coherence, proportionality and risk-based approach of any policy measures. Charles Faid EFPIA - European Federation of Pharmaceutical Industries and Associations Nathalie Moll

Discover the Africa Medicines Agency on CTC.AFRICA! Learn more about this crucial regulatory body and its role in advancing healthcare across the continent. Key points you'll find on the showcasing page: AMA's mission and vision: Understand their goals for regulating medicines in Africa. Regulatory framework: Explore the rules and guidelines governing the pharmaceutical industry. Key initiatives: Discover the AMA's ongoing projects and achievements. Visit CTC.AFRICA to explore the Africa Medicines Agency page and stay informed about the latest developments in African healthcare regulation. https://www.ctc.africa/ #CTCAfrica #AfricaMedicinesAgency #Healthcare #Regulation #Africa