The World Health Organization (WHO) has formally recognized 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.

"By expanding and diversifying the network of listed authorities, WHO and its Member States are moving closer to a more inclusive, efficient and globally connected regulatory ecosystem -one that supports equitable and timely access to safe, effective and quality-assured health products for all, everywhere," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data.

The WLA framework is central to WHO's efforts to strengthen regulatory systems globally and promote regulatory reliance, including through the WHO Prequalification Programme. By enabling other regulators, international agencies and procurement bodies to rely on the decisions of WLAs, the framework helps reduce duplication of regulatory work, ease supply bottlenecks and speed access to essential medicines and vaccines.

As the WLA network becomes more geographically diverse, it strengthens global and regional collaboration and supports more resilient supply chains, especially during health emergencies.

A rigorous, science-based process

WHO grants WLA status following a rigorous, science- and data-driven assessment based on internationally agreed standards. Through a voluntary process, regulatory authorities undergo a comprehensive technical evaluation to demonstrate advanced and reliable oversight across specific areas of medical product regulation. This process is part of a broader global effort to build strong, resilient and trustworthy regulatory systems.

A landmark achievement for middle-income countries

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. The listing reflects sustained political commitment and long-term investment in regulatory system strengthening, particularly for vaccine oversight in one of the world's largest and most complex health markets.

Indonesia's achievement demonstrates that advanced regulatory capacity is attainable across diverse resource settings, with tangible benefits for public health and health security. It is also expected to encourage other regulatory authorities, especially in low- or middle-income countries, to pursue similar pathways toward internationally recognized regulatory excellence.

Completing a global transition

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.

TGA's listing builds on its long-standing role as a reference authority for many regulators and procurement agencies worldwide, while reinforcing modern approaches that promote regulatory convergence, reliance and mutual trust.

Other national regulatory authorities have already submitted expressions of interest to enter the process, signaling growing momentum and confidence in the WLA framework.