規制動向
FDA、EMA、TGA および世界の規制動向
規制動向
2026年8月23日•1分で読めます
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.
規制動向
2026年5月18日•1分で読めます
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The US FDA has issued new draft guidance clarifying regulatory expectations for continuous manufacturing processes in drug substance production.
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規制動向
2026年5月16日•1分で読めます
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.
1.4K
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規制動向
2026年5月13日•1分で読めます
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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