The European Commission launched the Critical Medicines Alliance to address medicines shortages in the E.U. The alliance brings together policy makers, industry and patients to evaluate supply chain vulnerabilities and develop recommendations on mechanisms to prevent shortages. Read more: https://bit.ly/4be0jiA #AgencyIQ #Politico #LifeSciences #Regulatory #Regulation #EuropeanCommission
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The European Commission published the Union list of critical medicines. This list is one of the first steps in the Commission’s action plan to address medicine shortages and will provide a jumping off point for assessing supply chain vulnerabilities. Read our analysis here: https://bit.ly/3tEogQ9 #AgencyIQ #Politico #LifeSciences #Regulatory #Regulation #EuropeanCommission #EMA #Medicine
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The structural root cause of shortages lies in the pricing and #procurement of #OffPatent medicines, as evidenced in studies such as the Technopolis Study on medicines #shortages identifying the absence of supply security criteria in market policies as a major risk for the EU. The #EUPharmaStrategy review needs to address this issue, as suggested in our paper ➡ https://lnkd.in/d8536QbU ➡ https://lnkd.in/dSA9VwS3
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Group Company Secretary, Head of Compliance, Acting Chief Financial officer & Group HRM at FNE Group
UPDATE BY #BOI (PRIME MINISTER'S OFFICE) Pakistan Regulatory Modernization Initiative is paving the way for businesses to thrive in a supportive ecosystem! Through streamlined regulations to reduce business compliance burden, we're creating an environment where businesses can grow leading to enhanced economic activity. Validity Period of Drug Sale License has been increased from 02 years to 05 years by the Government of Sindh. For details: https://lnkd.in/dg-g538x #PRMI #RegulatoryReforsms #regulatorycompliance #investinpakistan #pharmaceuticalindustry #promotingdomesticindustry #localmanufacturers #genericdrugs #PakistanPharmaGrowth #HealthcareInnovation #DomesticIndustryRising #RisingDomesticPharma #InnovationInMedicine #HealthcareEvolution
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📄 Our Government & Public Affairs teams has been compiling key policy & regulatory developments in our Healthcare Bulletin for more than a year now. Get acquainted with the latest edition, including the following highlights: 📌 161 bln rub - Healthcare-related investments and deals signed at SPIEF 📌 A special list of biologically active supplements might be developed under a new project law 📌 Sale of expired drugs might soon be entirely banned in Russia As always, all regulatory highlights are accompanied by clickable links leading to source documents. ✉️ If you have any queries, please contact Georgy Halilulin #PBN #healthcare #pharmaindustry
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Follow Freyr Regulatory Roundup and get access to the latest Regulatory developments in the Life Sciences industry. Discover last week’s updates from global Health Authorities like USFDA, ANVISA, ASA, Swissmedic, BADAN POM, and more. https://lnkd.in/gkVUF57e #RegulatoryUpdates #LifeSciences #HealthAuthorities #FreyrRegulatoryRoundup #FreyrSolutions
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The clinical research sector has been working nonstop to provide better solutions globally as the need for new medications and treatments grows. However, the need for novel and easily accessible medications is growing, necessitating worries about implementation standards and safety. According to standard and international legislation, ethical and regulatory organizations play a critical role in sustaining the primary purpose of research to ensure the highest ethical and Biosafety standards. The National Bioethics Committee (NBC) and the Drug Regulatory Authority of Pakistan (DRAP) are the two main organizations that oversee the field of research in Pakistan. The NBC verifies that research is conducted in accordance with scientific principles, ethical standards, the reliability of the researcher, and any applicable laws, issues, or regulations. While DRAP oversees the trial and makes sure that it adheres to participant safety, justice, and effectiveness requirements. OrciTrials ensures that these criteria are implemented as it recognizes the importance of the regulations established by these organizations. https://lnkd.in/dfPMEmB4 https://lnkd.in/dCY5QX76 #regulatory #ethicalresearch #nbc #drap #rergualtoryapproval #regulatorycompliance #orcitrials
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Learn significant Regulatory developments released this week from prominent global health authorities like MHRA, USFDA, ANVISA, ECHA, etc. Read through Freyr Regulatory Roundup. https://lnkd.in/gafY3nQD #HealthAuthorities #RegulatoryUpdates #LifeSciences #FreyrSolutions #FreyrRegulatoryRoundup
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𝗘𝗻𝗳𝗼𝗿𝗰𝗲𝗺𝗲𝗻𝘁 𝗣𝗼𝗹𝗶𝗰𝗶𝗲𝘀 𝗳𝗼𝗿 𝗧𝗲𝘀𝘁𝘀 𝗗𝘂𝗿𝗶𝗻𝗴 𝗮 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟱𝟲𝟰 𝗗𝗲𝗰𝗹𝗮𝗿𝗲𝗱 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 & 𝗳𝗼𝗿 𝗖𝗲𝗿𝘁𝗮𝗶𝗻 𝗜𝗻 𝗩𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 https://lnkd.in/ePtQpSAZ 📆 𝐓𝐚𝐥𝐤 𝐰𝐢𝐭𝐡 𝐚𝐧 𝐞𝐱𝐩𝐞𝐫𝐭 👉 https://lnkd.in/e52sdG3P Section 564 Declaration: Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows the FDA to authorize the emergency use of medical products during public health emergencies. Emergency Use Authorization (EUA): An EUA allows the use of unapproved medical products or unapproved uses of approved medical products during emergencies. Public Health Emergency: These are situations where there is an urgent public health need for certain IVDs, but a declaration under Section 564 of the FD&C Act has not been made. Guidance: Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency FDA is issuing this draft guidance to describe the factors that the FDA intends to consider when deciding whether to issue an enforcement policy when a future declaration of an emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) is issued. Check out this guidance to know the Factors that you need to Consider in Deciding Whether to Issue an Enforcement Policy for Unapproved Tests. Contact BIOBOSTON CONSULTING today or visit our website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda #quality #compliance #qualityassurance #regulatoryaffairs
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In 2024, the U.S. Food and Drug Administration (FDA) will transition key export documents for #medicaldevices from paper to #digital format to reduce paperwork and streamline their workflow. Read the article: https://hubs.la/Q021FMFX0 Scan-Optics
IRS Launches Paperless Processing Initiative
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Product and Asset Management Director @ MENTOR Technical Group, Corp. | Asset Management, Digital Transformation, Operational Excellence, Smart Maintenance, Calibration
Among other facts: The most common CGMP citation in FY23 warning letters to drug manufacturing facilities involved quality units (21 CFR 211.22) followed closely by control and testing citations (21 CFR 211.84). In the top five citations of the year were written procedures and deviations (21 CFR 211.100), production record review, (21 CFR 211.192) and equipment cleaning and maintenance (21 CFR 211.67(b)). Find more details on FDA Citations for 2023 here: https://lnkd.in/ebSQkD-q
CDER’s Office of Compliance issued its 2023 Annual Report which highlights key initiatives and actions during the year to protect consumers and ensure the safety of our drug supply: https://lnkd.in/g_f9swua
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