Reforming the regulatory environment for innovative health technologies

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This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and patents. Doctrinal, qualitative and iterative research methods will be used. The primary intended outcome is a set of recommendations to assist policy makers in ensuring consistency of regulatory policy and practice, thereby supporting innovation and safe clinical translation, for the benefit of all Australians.