Veristat’s Post

The European Commission released the report on critical medicines supply chains of the Health Emergency Preparedness and Response Authority (HERA). The EU Commission/HERA launched the Critical Medicines Alliance to address shortages of critical medicines earlier this year. The report investigated the supply chains of 11 medicines from the Union list of critical medicines. Recommendations include: ➡ Diversifying supply sources ➡ Enhancing production capacity ➡ Developing risk management frameworks 🔗 https://hubs.li/Q02HtCfJ0 #pharmaceutical #healthcare

ℹ EMA’s Medicines Shortages Steering Group (MSSG) has developped new recommendations to strengthen the drugs supply chain. Those measures will be selected according to the risks posed to the supply chain and the type of medicine. - Possible recommendations to MAHs to increase manufacturing capacity and diversify the suppliers (for example through the addition of alternative manufacturing sites), and to monitor forecasts and demand of medicines and available stocks. - Recommendations to stockpile medicines to protect against fluctuations in demand or supply. - The possibility to request a MAH to establish a shortage prevention plan for medicines in the Union list of critical medicines. EMA will publish guidance and templates for shortage prevention plans in June 2024. - Provision of scientific and regulatory support to address vulnerabilities in the supply chain, including assistance to small and medium-sized enterprises. #drugs #medicines #supplychain #drugshortage #EMA #pharmaceutic https://lnkd.in/dyiNVvKr

Portugal safeguards access to medicines in the annual review of medicines pricing 📢   During the annual review of medicines prices in Portugal, the authorities have decided to introduce a mechanism allowing price adjustment with up to 3.5% price increase for medicines that are currently priced under 10 Eur. This is an important step towards safeguarding medicines security. Generic medicine manufacturers have faced growing expenses, during the COVID-19 pandemic, and more recently, as a consequence of the war in Ukraine, the gas crisis, high inflation and increase in cost of goods and regulation within a tightly regulated pricing framework.   📚 These measures align with the study on "New pricing models for #GenericMedicines to ensure long-term sustainable competition in Europe," highlighting the need for innovative pricing strategies to combat price erosion and ensure sustainable competition in off-patent medicines markets. ➡ https://lnkd.in/dcGeqCdX   Let's continue to ensure sustainable access to medicines for all!   #AccessForAll - APOGEN – Associação Portuguesa de Medicamentos Genéricos e Biossimilares

The European Medicines Agencies (EMA) and Heads of Medicines Agencies (HMA) joint strategy for 2028 marks a pivotal moment for life sciences management. This call for consultation underscores the critical need to adapt to a rapidly evolving medicines landscape, shaped by new legislation, technological innovations like AI, and emerging public health threats. For the life sciences sector, this strategy presents both challenges and opportunities—particularly in improving access to medicines, leveraging digital advancements for efficiency, and fostering a regulatory environment that enhances innovation and competitiveness. As EMA and HMA focus on sustainability, antimicrobial resistance, and medicines availability, the life sciences industry must engage proactively to ensure alignment with these strategic objectives. The consultation offers stakeholders a chance to influence how regulatory frameworks evolve to support cutting-edge advancements while addressing societal health needs. Ultimately, this strategy will shape the future of pharmaceutical development and regulation across the EU, making stakeholder input crucial for driving impactful, forward-thinking change. #regulatorygramwrok#healthneeds#EMA#sciencemanagement#lifesciencesindustry#innovationtechnology#AI#

Medicines for Ireland recognises that the shortages of vital medicines is not just a national challenge, but a challenge shared by all member states of the European Union. That is why we are committed to engaging with all European stakeholders to deliver a pharmaceutical policy that enhances medicine access, availability and sustainability. This can be achieved in a number of ways, including: 🔹 Providing legal certainty for generic and biosimilar medicines by modulating incentives based on public health objectives, leading to earlier competition. 🔹 Removing barriers to entry for off-patent medicines by clarifying the Bolar provision and facilitating administrative processes. 🔹 Rejecting transferable exclusivity vouchers (TEV) for novel antimicrobials, as they increase costs, reduce predictability, and delay access to critical therapies. 🔹 Exploring solidarity-based market models to reward innovation and ensure a secure supply of reserve antibiotics. The priority should be a European strategy aimed at preventing medicine shortages and addressing vulnerabilities in the global production chain by enhancing the efficiency and digitalisation of the medicines regulatory network. Alongside Medicines for Europe, MFI and our members stand ready and willing to engage with European policy makers as they map out the future of European health. With close co-operation we can ensure that patients have access to the vital medicines that they need to get healthy, stay healthy and live healthy. #Medicinesforall

Unlocking the Potential of Biosimilars in the EU Since 2006, the European Union has led the way in regulating biosimilars, ensuring they meet stringent standards of safety, quality, and efficacy. The European Medicines Agency (EMA) and the European Commission have released an Information Guide for healthcare professionals, detailing the science and regulations behind biosimilars. This guide covers the definition and development of biosimilars, the rigorous approval process, and key safety considerations, including comparability studies and immunogenicity. Key Highlights: The guide outlines the clinical study requirements for biosimilars, emphasizing the importance of demonstrating biosimilarity through robust scientific methods. It explains how biosimilars differ from generic medicines and provides insights into safety monitoring, post-marketing studies, and extrapolation of data. A glossary and list of abbreviations are included to clarify key terms related to biosimilars and regulatory processes. This resource is invaluable for healthcare professionals navigating the evolving landscape of biosimilar medicines in the EU.

Stay informed with the latest industry news! Explore the World Health Organisation's new draft guidelines targeting carcinogenic nitrosamine impurities in medicines. These guidelines, building on the efforts of the FDA and EMA, offer detailed advice on Good Manufacturing Practices, risk assessment, root cause analysis, and analytical procedures. This critical update aims to enhance the safety of drug products by ensuring rigorous identification and control of nitrosamine impurities, thereby maintaining the global supply of essential medicines. Read the full article here: https://okt.to/VTsou5 #PharmaceuticalSafety #Nitrosamines #WHOGuidelines #drugmanufacturing

EMA Grants Positive Opinion for Fexinidazole Treatment for Sleeping Sickness The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has approved Fexinidazole Winthrop, an oral treatment for the acute form of sleeping sickness caused by Trypanosoma brucei rhodesiense. This is the first-ever oral treatment for this form of sleeping sickness, which is a deadly parasitic disease prevalent in Eastern and Southern Africa. The approval covers both adults and children aged six or older, and both the initial and advanced stages of the disease. Sanofi's application and clinical trials conducted by DNDi were crucial in securing this approval. Fexinidazole Winthrop is prescribed as a 10-day, once-daily oral treatment and has shown remarkable effectiveness and safety in clinical trials. The approval will lead to updates in WHO guidelines and the distribution of the treatment in regions where sleeping sickness is prevalent. For more details please click the link! https://lnkd.in/dsAjvv9y #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

📢 TGA AUSTRALIA: Assessed Listed Medicines Evidence Guidelines (Version 1.2, April 2024) 📢 Are you involved in the development or marketing of complementary and over-the-counter medicines? If so, you’ll want to pay attention to the Assessed Listed Medicines Evidence Guidelines recently published by the Therapeutic Goods Administration (TGA). 🔍 What Are Assessed Listed Medicines? Assessed listed medicines are a unique category that bridges the gap between standard listed medicines (lower risk) and registered medicines (higher risk). These products contain low-risk ingredients and have higher-level indications than standard listed medicines. However, they don’t need to meet the extensive requirements for registration. Instead, they must have strong scientific evidence to support their efficacy. 🌟 Key Benefits of the Assessed Listed Medicines Pathway: Intermediate Level Indications: Assessed listed medicines allow sponsors to use intermediate level indications, providing more flexibility in labeling. Efficacy Assessment Claim: When approved by the TGA, these products can carry a label claim that their efficacy has been assessed for the approved indications. Data Protection Potential: Sponsors may benefit from data protection. 📚 Evidence Requirements: The guidelines provide detailed information on evidence requirements for different application categories. Let’s focus on the L(A)3 application category, which involves a de novo evaluation of efficacy. If you’re considering an assessed listed medicine, this section is crucial. Remember, ensuring the safety, quality, and efficacy of your product is essential. Stay informed and make evidence-based decisions! 💡 #TGA #AssessedListedMedicines #HealthcareRegulation #EvidenceBasedMedicine #ComplementaryMedicine #PharmaceuticalGuidelines

Massive stockpiling of medicines increases patient risks, warns EU coalition A coalition of six EU member states has warned against some countries' massive stockpiling of medicines, warning that such practices might cause significant shortages in other parts of the European Union. Pharma industry sounds alarm Medicines for Europe, an industry group representing generic and biosimilar medicines manufacturers, has also raised concerns about the extensive national stockpiling requirements. According to Medicines for Europe, the additional costs and complexity for manufacturers reduce the economic viability of low-price or low-volume medicines, aggravating market consolidation, increasing the risk of shortages, and threatening patient access to medicines. https://lnkd.in/dWB4Mwq9 #PublicHealth #Europe #StayInformed #StayEmpowered