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TGA Presentation: International collaboration – Why and with whom?

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TGA Australia
TGA Australia

An overview of why and how the TGA collaborates with international organisations, including examples.

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International collaboration Why and with whom? Harry Rothenfluh PhD Manufacturing Quality Branch
Why should we collaborate? 2
How do we collaborate? • Information sharing (especially compliance related) 3
How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • USFDA, Health Canada, EU regulators, MCC • WHO Prequalification, EDQM 4
How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections 5
How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections • Recognizing decisions made by equivalent regulators • GMP clearances issued for overseas manufacturers 6
How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections • Recognizing decisions made by equivalent GMP inspectorates • Others • International Coalition of Medicines Regulatory Authorities • Pharmaceutical Inspection Convention/PI Cooperation Scheme (PIC/S) 7
Questions 8

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Improved electronic submission methodologies - Challenges and future state
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Regulation, ethics and reimbursement of novel biological therapies in Austral...
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Updates to Good Manufacturing Practices - Recent, current and future changes
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Manufacturing Investigational Medicinal Products - Legislative and GMP requir...
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Update on regulatory reforms from the Scientific Evaluation Branch
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Reporting of Medicine Shortages
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Regulatory updates from the TGA Medical Devices Branch - Part 1
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SME Assist: Help to navigate the regulatory maze
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Presentation: Updates from the Pharmacovigilance and Special Access Branch
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Presentation: The challenges of regulating direct to consumer digital medical...
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TGA Presentation: International collaboration – Why and with whom?

  • 1. International collaboration Why and with whom? Harry Rothenfluh PhD Manufacturing Quality Branch
  • 2. Why should we collaborate? 2
  • 3. How do we collaborate? • Information sharing (especially compliance related) 3
  • 4. How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • USFDA, Health Canada, EU regulators, MCC • WHO Prequalification, EDQM 4
  • 5. How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections 5
  • 6. How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections • Recognizing decisions made by equivalent regulators • GMP clearances issued for overseas manufacturers 6
  • 7. How do we collaborate? • Information sharing (especially compliance related) • Joint GMP inspections • True worksharing on GMP inspections • Recognizing decisions made by equivalent GMP inspectorates • Others • International Coalition of Medicines Regulatory Authorities • Pharmaceutical Inspection Convention/PI Cooperation Scheme (PIC/S) 7