Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 23, 2026•1 min read
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.
Regulatory Updates
May 18, 2026•1 min read
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The US FDA has issued new draft guidance clarifying regulatory expectations for continuous manufacturing processes in drug substance production.
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Regulatory Updates
May 16, 2026•1 min read
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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Regulatory Updates
May 13, 2026•1 min read
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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