Australia and Indonesia Earn WHO Listed Authority Status, Marking Major Step in Global Medical Regulation.
WHO recognition highlights regulatory excellence, strengthens global access to safe and quality-assured medical products.
Geneva:
In a significant milestone for global health governance, the World Health Organization (WHO) has officially recognized the medical products regulatory authorities of Australia and Indonesia as WHO Listed Authorities (WLAs). The designation reflects the highest level of confidence in a country’s ability to regulate medicines, vaccines and other medical products in line with internationally agreed standards.
Australia’s Therapeutic Goods Administration (TGA) and the Indonesian Food and Drug Authority (BPOM) were granted the status following a rigorous, science-based evaluation conducted by WHO. With their inclusion, the global WLA network now comprises 41 regulatory authorities across 39 countries, signaling a more geographically diverse and inclusive system 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,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. She added that the framework supports “equitable and timely access to safe, effective and quality-assured health products for all, everywhere.”
Strengthening global regulatory reliance
The WLA framework is a cornerstone of WHO’s strategy to strengthen regulatory systems worldwide. Authorities recognized as WLAs are trusted reference agencies whose regulatory decisions can be relied upon by other countries, international organizations and procurement bodies. This approach reduces duplication of regulatory work, eases supply chain bottlenecks and accelerates access to essential medicines and vaccines—particularly during public health emergencies.
As the network expands across regions and income levels, it enhances global and regional collaboration and contributes to more resilient and responsive supply chains.
A rigorous, science-based process
WHO grants WLA status through a voluntary but comprehensive assessment process. Regulatory authorities must demonstrate advanced and reliable oversight across defined functions of medical product regulation, supported by strong governance, technical capacity and data-driven decision-making. The process reflects WHO’s broader effort to build trusted and resilient regulatory systems globally.
Landmark achievement for a middle-income country
Indonesia’s recognition marks a historic achievement. Its Food and Drug Authority has become the first standalone regulatory agency from a middle-income country to attain WLA status. The listing 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.
WHO officials noted that Indonesia’s success demonstrates that advanced regulatory capacity is achievable across diverse resource settings. It is expected to encourage other low- and middle-income countries to pursue internationally recognized regulatory pathways, strengthening global health security in the process.
Completing a global transition
Australia’s TGA listing also represents the completion of a major global transition. With this designation, all regulatory authorities previously classified as Stringent Regulatory Authorities (SRAs) have now formally moved into the WLA framework. This shift establishes a single, transparent and predictable global system that governments, WHO programmes and international procurers can rely on with confidence.
The TGA’s recognition builds on its long-standing role as a reference authority for regulators worldwide, while reinforcing modern approaches that promote regulatory convergence, reliance and mutual trust.
WHO confirmed that several other national regulatory authorities have already submitted expressions of interest to enter the WLA process, signaling growing momentum and confidence in the framework as a foundation for global regulatory cooperation.
