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Vicore Health: Your Gateway to African Market Growth As global regulatory demands increase, EU pharmaceutical and medtech companies are looking for smarter, more cost-effective ways to expand. Vicore Health provides ISO 9001-certified, tech-enabled regulatory services that enhance capacity, accuracy, and speed without adding overhead. Our offshore predominantly African based multilingual teams can integrate effortlessly with EU operations, offering reliable support across Regulatory Affairs, Pharmacovigilance, and Quality Assurance. From dossier compilation and publishing (CTD/eCTD) to variation management, IDMP and SPOR data support, and audit readiness, we combine automation, structure, and expertise to deliver clear efficiency improvements and confidence in compliance. Partner with Vicore Health to expand your team’s capabilities, shorten turnaround times, and achieve more with quality you can trust and efficiency you can measure. Learn more at www.vicorehealth.com #VicoreHealth #RegulatoryExcellence #Pharma #MedTech #MarketAccess #Pharmacovigilance #QualityAssurance #AfricaMarkets

Safer Veterinary Medicines for Africa: A Continental Initiative The African Union, AU-IBAR, AU-PANVAC, and partners including GALVmed and WOAH have launched the Pan-African Regulatory Authorities Network for Veterinary Products (PARAN-VPs). This new network will harmonise standards, share information, and coordinate oversight to ensure safe, effective, and affordable veterinary products reach livestock keepers across Africa. Over 350 million people depend on the continent’s livestock sector, yet substandard products, fragmented regulations, and high import dependence continue to undermine productivity and farmer livelihoods. By supporting coordinated regulation, PARAN-VPs will reduce costs, strengthen local production, and protect farmers from poor-quality products. Initiatives like this show how harmonised regulatory systems can improve access, build trust, and support sustainable development. At Vicore Health, we do not only focus on human health. Our expanding and existing animal health services also help strengthen regulatory systems and ensure safe medicines reach those who need them most. Find out more here: https://lnkd.in/dS9C5VMY #VicoreHealth #RegulatoryExcellence #AfricaHealth #VeterinaryMedicine #PARANVPs #Harmonisation #PatientAccess

South Africa Becomes First African Country to Approve Groundbreaking Anti-HIV Injection South Africa has made history with the registration of lenacapavir, a twice-yearly anti-HIV injection, marking the first approval of its kind on the continent. The approval, completed by SAHPRA in collaboration with the European Medicines for All Procedure, strengthens regulatory systems while speeding up patient access to essential medicines. Lenacapavir provides six months of protection with just two yearly doses, filling critical gaps in HIV prevention. Health authorities emphasise its potential to transform HIV prevention strategies, especially for populations at higher risk. Launch is planned as early as March 2026, with multi-stakeholder readiness discussions already underway. At Vicore Health, we support patient access by helping companies navigate regulatory pathways efficiently. Approvals like lenacapavir demonstrate how strong regulatory frameworks can deliver life-changing treatments to those who need them most. Find out more here: https://lnkd.in/dS9C5VMY #HIVPrevention #PatientAccess #Lenacapavir #SAHPRA #VicoreHealth #PharmaceuticalInnovation #AfricaHealthcare

Regulatory Progress in Kenya: Updates from SCoMRA 2025 Key announcements from SCoMRA VII in Mombasa signal important progress toward a more coordinated and efficient regulatory landscape in Africa. Experts emphasised that deeper collaboration between regulators and industry will be essential to strengthening medicinal product registration and improving the predictability of approval pathways. The discussion on the Continental Pilot for Listing of Human Medicinal Products highlighted the value of shared assessments and clearer alignment across agencies. AMA Director-General Dr Mimi Darko reaffirmed the Agency’s focus on accelerating treaty ratification, expanding capacity development, and supporting local manufacturing - all critical to achieving a functional and impactful continental authority. With 31 countries now having ratified the AMA Treaty, momentum continues to build around a unified regulatory system grounded in quality, trust, and reliance. Kenya also announced a strengthened partnership with AMA aimed at fast-tracking pharmaceutical approvals, reinforcing its leadership role in regional regulatory innovation. This collaboration reflects a broader shift across the continent toward reliance models that reduce duplication, shorten timelines, and improve patient access to essential medicines. At Vicore Health, we continue to track these developments closely to support partners with timely, contextualised regulatory intelligence. Found out more here: https://lnkd.in/dqsDFzXU #VicoreHealth #RegulatoryIntelligence #SCoMRA2025 #RegulatoryHarmonisation #AfricanMedicinesAgency #PharmaAfrica #MarketAccessAfrica #RelianceModels

Vicore Health to Attend SCoMRA 2025 Émile Malan, MBChB MBA will represent Vicore Health at the Scientific Conference on Medical Products Regulation in Africa (SCoMRA) 2025, held from 11–13 November in Mombasa, Kenya. This year’s theme, “Regulatory Harmonisation: Unlocking Africa’s Potential in Health Product Manufacturing and Trade,” highlights a shared commitment to improving regulatory collaboration for stronger health systems and better patient outcomes. The event offers an important platform for dialogue between regulators, policymakers, and industry leaders, paving the way for practical solutions that support local manufacturing, boost trade, and lay the foundation for a more unified and resilient regulatory landscape across the continent. As part of our vision to connect the world to the African pharmaceutical market, Vicore Health’s attendance underscores our dedication to staying closely aligned with the positive evolution of Africa’s regulatory ecosystem. By engaging with key stakeholders across regulatory authorities, industry, and policy circles, we aim to explore meaningful ways to actively contribute to ongoing harmonisation efforts and the future of regulatory excellence on the continent. This reflects our broader commitment to fostering collaboration, supporting capacity-building initiatives, and strengthening systems that ensure timely access to safe, effective, and high-quality health products for all patients across Africa. Find out more here: https://lnkd.in/ecyuTdqZ #SCoMRA2025 #RegulatoryHarmonisation #AfricanMedicinesAgency #HealthSystemsStrengthening #VicoreHealth #PharmaInAfrica

Driving Responsible Innovation: Vicore Health at the SAMED 2025 Regulatory Forum Vicore Health is excited to take part in the upcoming SAMED event, where our team will share insights on AI’s role in advancing regulatory excellence across the medtech sector. SAMED continues to promote ethical and sustainable medtech advancement in South Africa, and we’re excited to contribute our regulatory expertise to this expanding community. As part of this collaboration, Émile Malan, MBChB MBA, Berné Leuvennink, and Ruan Meyer from Vicore Health will speak at the SAMED Regulatory Forum on 18 November 2025, where the focus will be on AI’s evolving role in medical technology regulation. Their session will examine the rapid pace of change in the medtech sector, the emerging grey areas in oversight, and how trends from South Africa and the EU are shaping regulatory innovation. Key themes will include the rise of AI oversight roles such as the AI-QP, the growing use of automation, natural language processing, and regulatory intelligence, as well as the importance of integrating AI into workflows without compromising compliance or quality. For Vicore Health, this marks an important opportunity to extend our expertise into the evolving medtech space where AI, quality, and regulation increasingly converge. By engaging in these discussions, we’re reinforcing our commitment to helping the industry harness innovation responsibly while strengthening compliance, safety, and patient outcomes. Find out more about the event here: https://lnkd.in/ewbCzD5X #VicoreHealth #SAMED #MedTech #ArtificialIntelligence #RegulatoryAffairs #DigitalHealth #Innovation #Compliance