Scendea’s Post

📢 REGULATORY UPDATE - The Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance on 'Established Medicines marketing authorisation application process changes', detailing the process changes for 'Established Medicines', effective from 1 March 2024, which apply specifically to 'chemical' products.   Stay informed and compliant with the latest updates by accessing the guidance here: https://lnkd.in/d9p-tF6d With ERGOMED's expertise in regulatory affairs and unwavering dedication to upholding compliance with pertinent guidelines and regulations, we stand ready to offer invaluable regulatory support in navigating these changes. #MHRA #RegulatoryUpdate #EstablishedMedicines #ErgomedExpertise #ComplianceMatters #ClinicalResearch

Both Health Canada & the US FDA recognize multiple types of Drug Master Files, but did you know that the EMA only uses one? Here at SGS Nutrasource, we discuss #MasterFiles in detail so you can learn how and when to use them to bring your regulatory strategy to the next level. - #DrugMasterFiles #FDA #HealthCanada #EMA #RegulatorySubmissions

Discover the key learnings from new Medicines and Healthcare products Regulatory Agency guidance on a new international recognition route for medicines utilising pre-existing approvals! - The guidance outlines the changes to these products and describes the approaches that are taken as part of the new international recognition route. Find the full guidance here https://lnkd.in/dUxXTqdK - Are you seeking approval in the UK? Get in touch to understand how Scendea can support - info@scendea.com - #MHRA #GuidanceUpdate #IRP #DrugDevelopment #RegulatoryAffairs

Did you miss yesterday's Decentralized Manufacturing Working Group meeting on Regulatory Considerations, or want a recap? Ursula Busse (Tigen) & Ian Rees (Formerly Medicines and Healthcare products Regulatory Agency) presentation on Regulatory Aspects for Decentralized Manufacture, a comparison of how the UK, USA & EU regulatory bodies approach regulation, and the scope for international collaboration is available to view on the Phacilitate Network, along with the following open discussion. Let me know if you have any difficulty accessing this and the slides. #Decentralizedmanufacturing #celltherapy #pointofcare #celltherapymanufacturing #cellulartherapies #DCMWG #ICMRA #EMA #FDA #MHRA #regulatory

FDA finalizes guidances on RWD in regulatory submissions, assessing registries Country: USA https://lnkd.in/dpvbz9Q5 #FDARWDGuidance #RegulatorySubmissions #RealWorldData #AssessingRegistries #FDARegulatoryGuidance #HealthcareData #MedicalRegistries #RWDAssessment #ClinicalResearch #FDARegulatoryUpdates #EvidenceBasedMedicine #HealthcareGuidance #FDAInsights #RealWorldEvidence #RegistryAssessment #ClinicalTrials #HealthcareRegulations #FDAStandards #MedicalResearch #RegulatoryCompliance

🌍 Elevating Global Regulatory Collaboration in Pharmaceuticals 🏭 A significant stride in the pharmaceutical sector unveils as the Medicines and Healthcare products Regulatory Agency (MHRA) sheds light on the groundbreaking International Recognition Procedure (IRP) for medicines manufacturers. Released on September 4, 2023, this guidance follows the announcement to replace the EC Decision Reliance Procedure (ECDRP) starting January 1, 2024. The IRP ushers in a new era of collaboration with esteemed regulatory partners from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. This alliance aims to expedite patient access to cutting-edge medicines by leveraging collective expertise while preserving the MHRA's regulatory sovereignty. Amidst this evolution, the MHRA's adept response to the UK's separation from the EU is notable. Temporary EU 'reliance' routes ensured timely access to European-approved products in Great Britain. As these provisions conclude on December 31, 2023, the MHRA embarks on a public consultation, concluding September 27, 2023. https://lnkd.in/gbEGWdNF #pharmaceuticalinnovation #globalcollaboration #regulatoryaffairs #canada #europeanunion #japan #Australia #switzerland #pharmout PharmOut https://lnkd.in/gCiNMai4

THE CRUCIAL ROLE OF REGULATORY COMPLIANCE IN HEALTHCARE MARKETING 🤝 : In the pharmaceutical and medical device sectors, regulatory compliance is essential for effective marketing. #PatientSafety: Ensures all marketing practices prioritize patient well-being, as mandated by agencies like the FDA (U.S.), EMA (EU), and TGA (Australia). #Transparency: Guarantees accurate and honest product information, adhering to guidelines from bodies such as Health Canada and MHRA (UK). #GlobalReach: Facilitates smoother entry into international markets by complying with regulations from the WHO and other global entities. #BrandVoice: Strengthens a unified and credible brand voice by consistently adhering to regulatory standards. #BrandStrength: Enhances brand credibility and trust through adherence to standards set by regulatory agencies worldwide. #RiskMitigation: Reduces legal risks and potential fines by following the rules established by authorities like the PMDA (Japan) and ANVISA (Brazil). Regulatory excellence isn’t just about following the law—it’s about upholding the highest standards in healthcare. Let’s prioritize compliance for a stronger, more trustworthy industry. #Healthcare #Pharma #MedicalDevices #RegulatoryCompliance #Marketing #BrandVoice #BrandStrength #FDA #EMA #TGA #HealthCanada #MHRA #WHO #PMDA #ANVISA

Interested in global harmonization and regulatory CMC practices? Access this FREE session from WCBP 2024 on "Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation". This panel of esteemed regulatory experts, including representatives from ANVISA, US FDA, European Medicines Agency, PMDA, and World Health Organization, share their invaluable insights on global harmonization. https://hubs.li/Q02HTJgf0 #casss #cmc #wcbp2024 #wcbp #regulatory #GlobalHarmonization

"Transforming Global Regulatory CMC Practices in an Age of Revolutionary Innovation" A fantastic opportunity to access this extended (1h 45min) panel discussion on regulatory collaboration and reliance activities with representatives from #ANVISA #EMA #FDA #CBER and #CDER #PMDA and #WHO Panelists: Nélio Cézar De Aquino Ingrid Markovic Steven Kozlowski Nino Mihokovic Yasuhiro Kishioka, and Samvel Azatyan. The session included a short prentation about WHO’s efforts to build regulatory capacity in smaller agencies through regulatory system strengthening - for the benefit of patients around the world. Expertly moderated by #Amgen’s Nina Cauchon, FDA’s Maria T Gutierrez-Lugo and #Genentech’s Maria Cecilia Tami It was a huge honour and pleasure to help write this session up for two of the International Pharmaceutical Quality weekly supplements. If you’d like to read the full comments as well as access the recording, feel free to get in touch! #cmc #regulatoryaffairs #reliance #collaboration #partnerships #trust

Monitoring the Regulatory advancements in the Life Sciences industry is complex. Freyr Regulatory Roundup provides weekly insights on the upcoming Regulatory changes. Learn more about the latest Regulatory updates from the US FDA, ANVISA, EMA, NPRA, HC, SFDA, ECHA, etc., in detail. Read through Freyr Regulatory Roundup. https://lnkd.in/gzeZiE_6 #LifeSciences #RegulatoryUpdates #FreyrRegulatoryRoundup #HealthAuthorities #FreyrSolutions