Australia and Indonesia Secure WHO Listed Authority Status, Strengthening Global Medical Regulation
World Health Organization recognition affirms excellence of regulatory systems and supports broader access to high-quality medical products
The World Health Organization has formally designated Australia’s Therapeutic Goods Administration and Indonesia’s Food and Drug Authority as WHO Listed Authorities for medical products regulation, a distinction awarded to regulatory bodies that meet the organisation’s most rigorous international standards.
The latest listings expand the WHO Listed Authority network to include 41 regulatory authorities across 39 countries, reflecting a more inclusive and geographically diverse regulatory ecosystem.
WHO officials emphasised that broader participation in the framework supports equitable and timely access to safe, effective and quality-assured medicines, vaccines and diagnostics globally, and strengthens international confidence in national regulatory systems.
Achieving WHO Listed Authority status involves a voluntary, science-based evaluation process that examines comprehensive regulatory functions including product evaluation, market surveillance and oversight of complex health products.
Australia’s Therapeutic Goods Administration, long regarded as a reference authority, completes the transition of previously classified stringent regulatory authorities into the unified WHO Listed Authority framework, reinforcing its role in global regulatory cooperation and mutual recognition.
The Indonesian Food and Drug Authority’s recognition marks a landmark achievement for a standalone regulator from a middle-income country, underscoring years of sustained political commitment and investment in regulatory capacity, particularly for vaccine oversight in one of the world’s largest health markets.
WHO and partner agencies said the expanded network will help reduce duplication of regulatory work, ease supply chain bottlenecks and accelerate access to essential health products, particularly in times of health emergencies.
Authorities from additional countries have already expressed interest in the listing process, signalling growing momentum behind global regulatory harmonisation and collaboration to uphold quality standards and protect public health worldwide.
The latest listings expand the WHO Listed Authority network to include 41 regulatory authorities across 39 countries, reflecting a more inclusive and geographically diverse regulatory ecosystem.
WHO officials emphasised that broader participation in the framework supports equitable and timely access to safe, effective and quality-assured medicines, vaccines and diagnostics globally, and strengthens international confidence in national regulatory systems.
Achieving WHO Listed Authority status involves a voluntary, science-based evaluation process that examines comprehensive regulatory functions including product evaluation, market surveillance and oversight of complex health products.
Australia’s Therapeutic Goods Administration, long regarded as a reference authority, completes the transition of previously classified stringent regulatory authorities into the unified WHO Listed Authority framework, reinforcing its role in global regulatory cooperation and mutual recognition.
The Indonesian Food and Drug Authority’s recognition marks a landmark achievement for a standalone regulator from a middle-income country, underscoring years of sustained political commitment and investment in regulatory capacity, particularly for vaccine oversight in one of the world’s largest health markets.
WHO and partner agencies said the expanded network will help reduce duplication of regulatory work, ease supply chain bottlenecks and accelerate access to essential health products, particularly in times of health emergencies.
Authorities from additional countries have already expressed interest in the listing process, signalling growing momentum behind global regulatory harmonisation and collaboration to uphold quality standards and protect public health worldwide.
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