Regulatory Affairs
Page 1 • 8 itemsNavigate global pharma regulatory affairs. Get expert insights on FDA, EMA, and global compliance for drug approvals, market access, and R&D strategy.
EMA Establishes Expert Panel to Strengthen COVID-19 mRNA Vaccine Trust Including Spikevax and Comirnaty
European Medicines Agency forms international expert panel to enhance public confidence in COVID-19 mRNA vaccines including Spikevax and Comirnaty.
SQ Innovation's Lasix ONYU Receives CE Marking Approval, Advances Toward European Market Authorization
SQ Innovation announces CE marking for Lasix ONYU medical device under EU MDR, plus EMA centralized procedure eligibility for European market expansion.
Zentiva Appeals EU Court Decision on Urban Wastewater Directive Affecting Generic Medicine Access
Zentiva and generic drugmakers challenge EU Urban Wastewater Directive at CJEU, citing concerns over patient access and medicine affordability in Europe.
EMA Issues Positive Opinion for Redemplo (Plozasiran) in European Drug Approval Process
European Medicines Agency issues positive opinion for Redemplo (plozasiran) marking significant step toward EU market authorization for this novel therapy.
EMA CHMP Recommends 6 New Medicines for Approval Including Treatments for Menopause, Liver Disease, and Rare Disorders
European Medicines Agency's CHMP recommends 6 new medicines for marketing authorization, covering menopausal symptoms, liver disease, and rare genetic disorders.
New Additional Risk Minimization Measures (aRMMs) Training Course Launches to Enhance Pharmaceutical Patient Safety Protocols
PharSafer Associates launches comprehensive aRMMs training course focusing on regulatory frameworks and patient safety evaluation strategies for pharma professionals.
SAHPRA and African Medicines Agency Launch Continental Pharmaceutical Regulatory Harmonization Course for May 2026
SAHPRA partners with African Medicines Agency for comprehensive regulatory affairs course covering continental harmonization and product registration.
MENA Medical Device Regulatory Training Course Launches May 2026 to Address Growing Market Demand
New MENA medical device regulatory training course scheduled for May 18-19, 2026, helps companies navigate approval processes in growing Middle East markets.