The World Health Organization (WHO) has formally recognised the regulatory authorities of Australia and Indonesia as WHO Listed Authorities (WLAs), marking a significant milestone in global efforts to strengthen trust and consistency in medical product regulation.

Australia’s Therapeutic Goods Administration (TGA) and the Indonesian Food and Drug Authority have both met WHO’s highest international standards for regulating medicines, vaccines and other health products. With their inclusion, the global WLA network now comprises 41 regulatory authorities from 39 countries, reflecting a more diverse and inclusive global landscape of regulatory excellence.

Welcoming the development, Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, said the expansion of the WLA network would help build a more connected and equitable regulatory ecosystem. She noted that a stronger and more geographically diverse network supports timely access to safe, effective and quality-assured health products for people everywhere.

The WLA framework plays a central role in WHO’s strategy to strengthen regulatory systems worldwide and promote regulatory reliance. By allowing regulators, international agencies and procurement bodies to rely on the decisions of WHO Listed Authorities, the framework reduces duplication of regulatory work, eases supply bottlenecks and accelerates access to essential medicines and vaccines. This approach has become particularly important during public health emergencies, when rapid and reliable regulatory decisions can save lives.

WHO grants WLA status through a rigorous, science- and data-driven evaluation based on internationally agreed standards. Regulatory authorities voluntarily undergo comprehensive technical assessments to demonstrate advanced oversight capabilities across specific areas of medical product regulation. The process is designed to support the development of strong, resilient and trustworthy regulatory systems globally.

Indonesia’s inclusion is being widely seen as a landmark achievement. The Indonesian Food and Drug Authority is the first standalone regulatory authority from a middle-income country to attain WLA status. The recognition reflects sustained political commitment and long-term investment in regulatory system strengthening, particularly in vaccine oversight within one of the world’s largest and most complex health markets.

Health experts say Indonesia’s success sends a strong signal that advanced regulatory capacity is achievable across diverse resource settings. It is also expected to encourage other regulatory authorities, especially in low- and middle-income countries, to pursue internationally recognised pathways to regulatory excellence.

Australia’s TGA listing marks the completion of a global transition process. With this designation, all authorities previously classified as “stringent regulatory authorities” have now formally moved into the WLA framework. This shift establishes a single, transparent and predictable global system that countries, WHO programmes and international procurers can rely on with confidence.

The TGA’s inclusion builds on its long-standing role as a reference authority for regulators and procurement agencies worldwide, while reinforcing modern regulatory approaches that emphasise convergence, reliance and mutual trust.

WHO officials noted that several other national regulatory authorities have already expressed interest in entering the WLA process, signalling growing momentum and confidence in the framework as a cornerstone of global health security and access to quality medical products.