The 2019-2020 plan details how TGA intends to advance the Government’s Regulatory Reform Agenda. Of particular note in the plan is the implementation of the Action Plan for Medical Devices, a significant program of regulatory reform, also with a focus on greater transparency and more consumer involvement in the regulatory process.
Some of the key actions included in the plan are:
- how TGA intends to meet public expectations in relation to the safety, efficacy, performance, quality and timely availability of therapeutic goods
- how TGA is responding to innovation in therapeutic goods and emerging public health issues to maintain the best possible outcomes for the Australian public
- implementation of the Action Plan for Medical Devices
- international collaboration between regulators to build regulatory best practice, increase collaboration on product reviews and post market monitoring as well as influencing international regulatory policy
- ongoing education and better, clearer regulatory guidance for industry
- how TGA plans to undertake appropriate and targeted compliance and enforcement activities.
Should you have any questions or comments in relation to the Business Plan please contact RegulatoryEngagement@health.gov.au