Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
Actualizaciones regulatorias
23 ago 2026•1 min de lectura
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.
Actualizaciones regulatorias
18 may 2026•1 min de lectura
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The US FDA has issued new draft guidance clarifying regulatory expectations for continuous manufacturing processes in drug substance production.
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Actualizaciones regulatorias
16 may 2026•1 min de lectura
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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Actualizaciones regulatorias
13 may 2026•1 min de lectura
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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