Australia's Department of Foreign Affairs and Trade is partnering with the Therapeutic Goods Administration (TGA) to co-deliver the Indo-Pacific Regulatory Strengthening Program (RSP). This program extends the previous TGA-led RSP and covers 22 countries across our region.
Over the next four years, RSP will work with countries that have a National Regulatory Authority (NRA) to strengthen health systems and build capacity. This includes ensuring that the NRAs have the tools necessary to perform regulatory functions effectively, fit-for-purpose processes, and adequately trained regulatory staff.
Responsive regulatory support will provide demand-driven assistance, recognising that many supported countries lack regulatory authorities. An on-call support system will help to address the specific regulatory needs of partner countries.
TGA is achieving its goals through enhanced reliance and cooperation mechanisms, improved regulatory tools, and the design of participatory GEDSI-sensitive regulatory systems. These efforts focus on key components which make up a strong regulatory system: quality, safety, efficacy of medical products, and strong risk communication.