The World Health Organization (WHO) has formally recognized the medical products regulatory authorities of Australia and Indonesia as WHO Listed Authorities (WLAs), marking a significant milestone in global regulatory trust across diverse regions and income levels.
Australia’s Therapeutic Goods Administration (TGA) and the Indonesian Food and Drug Authority have met WHO’s highest international benchmarks for medical products regulation. With their inclusion, the global WLA network has expanded to 41 authorities across 39 countries, reflecting a more inclusive and geographically diverse landscape of regulatory excellence.
The WLA framework plays a central role in WHO’s efforts to strengthen regulatory systems and promote regulatory reliance, including through the WHO Prequalification Programme. By allowing regulators, international agencies and procurement bodies to rely on decisions taken by WLAs, the framework reduces duplication, eases supply constraints and accelerates access to essential medicines and vaccines.
As the network grows more geographically diverse, it also enhances regional collaboration and strengthens supply chain resilience, particularly during public health emergencies.
WHO grants WLA status following a rigorous, science- and data-driven evaluation based on internationally agreed standards. Regulatory authorities voluntarily undergo comprehensive technical assessments to demonstrate advanced and reliable oversight across specific regulatory functions, as part of a broader global push to build resilient and trustworthy regulatory systems.
Indonesia’s Food and Drug Authority has made history by becoming the first standalone regulatory agency from a middle-income country to achieve WLA status. The recognition reflects sustained political commitment and long-term investment in regulatory capacity, especially in vaccine oversight within one of the world’s largest and most complex health markets. The achievement is expected to encourage other low- and middle-income countries to pursue similar pathways toward international regulatory recognition.
With the listing of Australia’s TGA, all regulators previously designated as “stringent regulatory authorities” have now transitioned into the WLA framework. This completes WHO’s planned shift to a single, transparent and predictable global regulatory system that countries, WHO programmes and international procurers can rely on with confidence.
TGA’s recognition builds on its long-standing role as a global reference authority, reinforcing modern approaches to regulatory convergence, reliance and mutual trust. Meanwhile, several other national regulators have already expressed interest in entering the WLA assessment process, signalling growing momentum and confidence in the framework worldwide.
