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Biologicals Regulation in Australia

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Albert Farrugia
Albert Farrugia
NegóciosTecnologia
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Biologicals regulation in Australia Evolving perspectives Albert Farrugia Senior Principal Research Scientist Therapeutic Goods Administration Presented to the Second Asian Bio Manufacturing Conference, Kuala Lumpur, Malaysia, November 2007
Current position ,[object Object],[object Object],[object Object],[object Object]
Current responsibilities Biologicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Role of the Blood and Tissues Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
International relationships BTU ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Current structure Blood and Tissues Unit ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Medical Advisor ODBT
Drivers for change Biologicals regulation in Australia ,[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulation of biologicals Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory model for biologicals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Organs Blood Progenitor (stem) cells Hospital based manufacture Banked blood components Banked tissues Processed cells and tissues Manufactured blood products “ Class III” – homologous function “ Class IV” – non-homologous function Plasma products Recombinant plasma products Processed blood components eg virally inactivated platelets Currently exempt Currently regulated through GMP – no ARTG Currently regulated as medicines or therapeutic devices “ listable” Biologicals – no efficacy requirements “ registrable” Biologicals –efficacy requirements Proposed regulatory model for Biologicals
Clinical trial framework Proposed approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],Haemovigilance Rapid Report generated by hospital Adverse event in public or private hospital and/or pathology service Health Department Regulator TGA Supplier Rapid validation process

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Biologicals Regulation in Australia

  • 1. Biologicals regulation in Australia Evolving perspectives Albert Farrugia Senior Principal Research Scientist Therapeutic Goods Administration Presented to the Second Asian Bio Manufacturing Conference, Kuala Lumpur, Malaysia, November 2007
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