The Indo-Pacific Regulatory Strengthening Program (RSP)

Regulation challenges

The regulation of medical products to ensure safety and effectiveness requires a complex series of activities from manufacture to patient use. In well resourced, high income countries, these activities are carried out by stringent regulatory authorities in a robust and efficient manner, enabled in many cases through international collaboration, information exchange and reliance mechanisms. Such cooperative approaches reduce duplication of work and functions and allow resources to be allocated to those regulatory functions where they are most required.

In lower resource contexts, the barriers to efficient and effective medical product regulation are harder to overcome. Less developed regulation can lead to delays in new products reaching market, the spread of substandard and falsified products, and increased patient risks if adverse drug reactions are not detected and managed. These risks can undermine the public health impact of new and existing medical products and delay disease elimination targets.

How will we address the challenge?

Supporting national medicines regulatory authorities to work together effectively improves the impact and safety of medical products through more efficient regulation. To this end, Australia’s Therapeutic Goods Administration is working with key Indo-Pacific counterparts to improve their regulatory systems and processes, including through sharing regulatory information.

Where?

Cambodia, Indonesia, Laos PDR, Myanmar, Papua New Guinea, Thailand, and Vietnam.

Partner:

The Therapeutic Goods Administration, through Australia’s Department of Health - up to $17 million 2018-2022.

What will success look like?

Partner countries have improved capabilities to regulate medical products, including stronger market authorisation systems, through institutional partnerships with Australia’s Therapeutic Goods Administration.