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Australia: TGA business plan 2021-22 is now available

2021/09/01  TGA

The health landscape has changed significantly since 2020, following the declaration of COVID-19 as a major health pandemic. The Australian public has looked to the Therapeutic Goods Administration (TGA) more than ever to assist in making informed choices about the products they use to maintain their health. Our response to these challenges demonstrated our ability to innovate and to improve our business processes. We will build on these process improvements through, for example, the better use of available health administrative data, improved data analytics and the implementation of the TGA digital transformation agenda. We will continue to engage closely with the pharmaceutical and the medical technology sectors, health care professionals and consumer groups. This engagement is essential in the development of flexible but robust regulatory evaluation processes, and expedited access for the Australian health sector, without compromising our regulatory standards. Through our work with supply chain stakeholders, we have implemented new ways of gathering intelligence about potential medicine and device (e.g. personal protective equipment) shortages. The monitoring and management of medicine shortages will continue in 2021-22 with new arrangements for monitoring wholesaler data and working closely with healthcare professionals and consumer organisations to provide public information about shortages.

We will also continue to progress digital transformation to streamline our business systems and modernise IT infrastructure. This will facilitate simpler, faster interactions with the TGA. It will also allow for greater transparency in the regulation of medicines and medical devices.

All the while, our people remain our greatest asset. They continue to demonstrate the outstanding commitment they have made during the COVID-19 pandemic to protecting the health and safety of the community in all facets of regulatory activity. We will continue to invest in capability development and new ways of working to build the workforce we need to deliver a world class, efficient, and timely regulatory system for therapeutic goods. We are committed to maintaining a culture where all our employees feel respected and included and focus on our regulatory science capability outlined in the HPRG Regulatory Science Strategy 2020 – 2025.

The TGA’s role as a regulator has never been so clear. In 2021-22, we will continue to increase our engagement with patients, consumers, and health professionals by strengthening relationships with representative bodies and individuals. We will provide additional information for healthcare professionals to clarify regulatory requirements and application processes for high-risk devices.

Through our commitment to international engagement and supporting Australia’s health security, we will continue to provide critical support and play a key role in supporting the safe, effective and timely roll-out of COVID-19 vaccines in South East Asia and the Pacific.

Our Business Plan sets out our product regulation, regulatory reform, international engagement, and regulatory education and compliance agenda for 2021–22. It supplements the Health Portfolio Budget Statements, the Department of Health Corporate Plan, and is supported by the Australian Government’s Regulator Performance Framework.

**Our priorities for 2021-22 **

  • Product regulation and safety – including COVID-19 medicines, vaccines and medical devices, and digital transformation.
  • Regulatory reform – through consulting on and implementing initiatives following policy approval from government.
  • International engagement – through activities that promote international information sharing, work sharing, collaboration and regulatory convergence, as well as programs for regulatory strengthening/assistance, and medicines testing in our region.
  • Regulatory education and compliance – through education, monitoring, targeted compliance and enforcement activities and appropriate action

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