Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
MHRA Issues Field Safety Notices for 1‑5 June 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a series of Field Safety Notices between 1 and 5 June 2026, outlining safety actions for several medicines and medical devices.
Regulatorische Updates
18. Mai 2026•1 Min. Lesezeit
FDA Releases Updated Guidance on Continuous Manufacturing for Drug Substances
The US FDA has issued new draft guidance clarifying regulatory expectations for continuous manufacturing processes in drug substance production.
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Regulatorische Updates
16. Mai 2026•1 Min. Lesezeit
EMA Updates GMP Requirements for Advanced Therapy Medicinal Products
The European Medicines Agency has published revised GMP guidelines for ATMPs including gene therapies, cell therapies, and tissue-engineered products.
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Regulatorische Updates
13. Mai 2026•1 Min. Lesezeit
ICH Q12 Implementation: Post-Approval Change Management Protocols
A practical overview of how pharmaceutical manufacturers are implementing ICH Q12 lifecycle management principles into their post-approval change management workflows.
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