On 21 May 2013, the Department of Health and Ageing issued a revised Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy (HCT) products. The proposed update seeks to improve the safety and quality of HCT products supplied in Australia. The update intends to align manufacturing requirements with industry practice and international regulation. The update will also remove technical requirements from the Code which will be transferred to a new Therapeutic Goods Order: Standards for minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products. This instrument will clarify the requirements for minimisation of infectious disease transmission through the selection and testing of donors of HCT products, and will align regulation of HCTs with the regulation of other therapeutic goods in Australia and internationally. The costs and benefits of the revision are difficult to quantify. The majority of manufacturers affected by this update must already comply with the existing Code, and as the revised Code is principles-based it allows flexibility in practice so the costs are expected to be limited. The introduction of internationally harmonised infectious disease minimisation criteria results in a small reduction in eligible donors and a minor increase in resource costs for some facilities. The revised Code and Therapeutic Goods Order will be effective from 31 May 2013, and allow a 12 month transition period. A Regulation Impact Statement was prepared by the Department of Health and Ageing and assessed as adequate by the Office of Best Practice Regulation.
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