Australia and Indonesia achieve WHO Listed Authority status in medical products regulation

December 26, 2025 | Friday | News

New listings mark a milestone for regulatory excellence

image credit- freepik

image credit- freepik

The World Health Organization (WHO) has formally recognised the regulatory authorities for medical products of Australia and Indonesia as WHO Listed Authorities (WLAs), an achievement that underscores growing global confidence in regulatory systems across diverse regions and income settings.

Australia’s Therapeutic Goods Administration (TGA) and The Indonesian Food and Drug Authority have both met WHO’s highest international standards in medical products regulation. With their addition, the global WLA network now comprises 41 authorities from 39 countries, reflecting a broader and more inclusive geography of regulatory excellence.

The Indonesian Food and Drug Authority has become the first regulatory authority from a middle-income country to achieve WLA status as a standalone agency.

With the designation of Australia’s TGA, all regulatory authorities previously classified as “stringent regulatory authorities” (SRAs) have now formally transitioned into the WLA framework. This completes a carefully planned shift toward a single, transparent and predictable global system that countries, WHO programmes and international procurers can rely on with confidence.

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