House of Reps Inquiry Into the Approval Processes For New Drugs and Novel Medical Technologies

The House of Representatives Standing Committee on Health, Aged Care and Sport will inquire into the approval processes for new drugs and novel medical technologies in Australia, with a particular focus on those for the treatment of rare diseases and conditions where there is high and unmet clinical need.

This inquiry will consider the following topics so that Australia continues to be well positioned to access new drugs and novel medical technologies in a timely manner and respond to emerging global trends:

1. The range of new drugs and emerging novel medical technologies in development in Australia and globally, including areas of innovation where there is an interface between drugs and novel therapies;
2. Incentives to research, develop and commercialise new drugs and novel medical technologies for conditions where there is an unmet need, in particular orphan, personalised drugs and off-patent that could be repurposed and used to treat new conditions;
3. Measures that could make Australia a more attractive location for clinical trials for new drugs and novel medical technologies; and
4. Without compromising the assessment of safety, quality, efficacy or cost-effectiveness, whether the approval process for new drugs and novel medical technologies, could be made more efficient, including through greater use of international approval processes, greater alignment of registration and reimbursement processes or post market assessment.