Regulatory Compliance
Page 1 • 11 itemsNavigate global pharma regulatory compliance. Get critical intelligence on FDA, EMA, and global health authority updates for your business strategy.
Bio-Rad Q1 2026 Results Show IVDR Compliance Costs Impact European Diagnostics Operations
Bio-Rad reports Q1 2026 financial results highlighting increased costs from EU IVDR compliance and product portfolio rationalization in diagnostics market.
FDA Real-World Evidence Framework Shifts $10B Toward Validated Medtech Platforms Like VentriPoint
FDA's new real-world evidence requirements for medical devices create $10B market shift favoring established platforms with proven performance data.
SamaCare Launches Industry-First Prior Authorization Performance Benchmarks for Medical Benefit Drugs
SamaCare introduces first-of-its-kind benchmarks tracking prior authorization approval rates and time to therapy across specialty practices nationwide.
Pet Service Holding Reports 2025 Annual Results Amid European Veterinary Regulatory Changes
Pet Service Holding NV announces 2025 annual results showing strategic transition while navigating evolving European veterinary medicine regulations.
Pharmaceutical Isolators Market Reaches $7.82 Billion as EU GMP Annex 1 Drives Manufacturing Safety Requirements
The global pharmaceutical isolators market hits $7.82 billion, driven by EU GMP Annex 1 regulations and rising HPAPI production demands through 2031.
Mabwell Achieves First PIC/S GMP Compliance Certification from Jordan FDA for Biopharmaceutical Manufacturing
Mabwell's T-mab subsidiary passes Jordan FDA GMP inspection, marking first PIC/S regulatory compliance for the Chinese biopharmaceutical company's manufacturing.
EMA IRIS System Updates: New Account Requirements for PSUR Submissions Starting September 2025
EMA announces mandatory IRIS account requirements for PSUR submissions and delays iMAA go-live to Q1 2026, affecting pharmaceutical companies across Europe.
EMA Drug Patent Cliff 2026: Major European Pharmaceutical Exclusivities Set to Expire
Multiple high-cost EMA-approved drugs lose exclusivity in 2026, enabling generic competition and expanded patient access across Europe's healthcare systems.
Medical Device Software Compliance Training Launches for EU MDR, IVDR and FDA Regulations in June 2026
New online training course addresses critical medical device software compliance requirements under EU MDR, EU IVDR, and FDA regulations starting June 22-26, 2026.
New Clinical Trial Monitoring Course Addresses Rising GCP Compliance Issues in Biopharmaceutical Industry
Online GCP compliance course launches June 2026 to address increasing regulatory inspection findings in clinical trial monitoring across biopharma and CROs.
New GCP Inspections Training Course Addresses ICH GCP E6(R3) and EU CTR Compliance for Pharmaceutical Companies
ResearchAndMarkets.com announces comprehensive GCP inspections training covering EU, FDA, and MHRA expectations under updated ICH GCP E6(R3) guidelines.