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Cell, tissue and gene therapies – Regulatory challenges and responses in Australia | Hogan Lovells

Published: November 19, 2022

Australian regulation of cell, tissue, and gene therapies (CTGT) is relatively new, with the regulatory framework for biological medical products first being introduced in 2011. A...

Source: jdsupra.com

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National One Stop ShopOffice Of The Gene Technology RegulatorAdvisory CommitteeTissue Regulatory FrameworkStakeholder PerspectiveClinical Trial ApprovalClinical Trial NotificationGene Technology RegulatorPharmaceutical Benefits Advisory CommitteeAustralian RegisterTherapeutic GoodsTherapeutic Goods RegulationsTherapeutic Goods ActDigital Transformation Project