규제 업데이트
FDA, EMA, TGA 및 글로벌 규제 동향
규제 업데이트
2026년 5월 18일•3분 읽기
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The US FDA has issued new draft guidance clarifying regulatory expectations for continuous manufacturing processes in drug substance production.
규제 업데이트
2026년 5월 16일•3분 읽기
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.
규제 업데이트
2026년 5월 13일•3분 읽기
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.