Consultation on Medical Products Roadmap: Response to the Department of Industry, Science, Energy and Resources Survey

This submission to the Department of Industry, Science, Energy and Resources responds to its survey on the Modern Manufacturing Initiative and the proposed Medical Products Roadmap. Answering the survey questions, Research Australia maintains that the medical products national manufacturing priority should cover not only commercial production but also manufacture of materials for clinical trials from Phase 2 onwards. Small-batch manufacture to Good Manufacturing Practice (GMP) standard would support Australia as a clinical trial destination, build expertise in new types of medicines, and provide a base for scaling successful products to commercial manufacture onshore. It identifies capital and skills as the main barriers, particularly in areas of Australian strength such as RNA-based therapies. Proposed measures of success include replacing imported trial materials, attracting more international trials, supplying overseas trial sites and commercial-scale manufacture. It refers to a proposal being developed with the Australian RNA Production Consortium.