WHO Grants WLA Status to Australia, Indonesia, Marking Milestone in Global Regulation

With Australia’s Therapeutic Goods Administration (TGA) and Indonesia’s Food and Drug Authority joining the network, the WLA system now includes 41 authorities across 39 countries.

The World Health Organization (WHO) has officially recognized the medical product regulatory authorities of Australia and Indonesia as WHO Listed Authorities (WLAs)—a designation reserved for regulatory bodies that meet the highest international standards for safety, quality and efficacy oversight. This milestone not only reinforces global confidence in both countries’ regulatory systems but also reflects a growing geographical diversity within the global regulatory landscape.

With Australia’s Therapeutic Goods Administration (TGA) and Indonesia’s Food and Drug Authority joining the network, the WLA system now includes 41 authorities across 39 countries. This expansion signals a substantive shift toward a more inclusive and interconnected global regulatory ecosystem that supports equitable access to health products.

A Stronger Global Regulatory Network

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, highlighted the importance of broadening the WLA network:

“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.”

The WLA framework plays a central role in strengthening regulatory systems globally. It encourages regulatory reliance, allowing governments, international procurement bodies, and health agencies to trust and use the decisions of WLAs—reducing duplication, easing supply chain bottlenecks and accelerating access to essential medicines, diagnostics and vaccines.

This reliance is also foundational to the WHO Prequalification Programme, which supports global supply of assured-quality health products, particularly during public health emergencies.

How Authorities Earn WLA Recognition

Achieving WLA status requires passing a rigorous, science-based evaluation aligned with international regulatory benchmarks. Participation is voluntary, yet extensive: regulators must demonstrate advanced capacity across a range of technical areas such as product evaluation, market surveillance, clinical trial oversight, and regulatory decision-making.

Assessments are built on:

• Comprehensive data reviews

• In-depth documentation of regulatory performance

• Demonstrated capacity to oversee complex health products

• Transparent, consistent and evidence-based regulatory operations

This demanding process is part of WHO’s broader mission to build trusted, resilient and high-performing regulatory systems worldwide.

Indonesia: A Breakthrough for Middle-Income Countries

Indonesia’s Food and Drug Authority becomes the first middle-income country to achieve WLA recognition as an independent national regulatory agency—an achievement with global implications.

Indonesia’s milestone reflects:

• Years of political commitment

• Sustained investment in regulatory governance

• Advanced oversight of vaccines and biological products

• Strengthened systems for one of the world’s most populous health markets

This progress demonstrates that regulatory excellence is attainable in diverse economic contexts, paving the way for other low- and middle-income countries to pursue WLA designation. Indonesia’s achievement may accelerate regional regulatory strengthening and enhance global vaccine readiness and health security.

Australia Completes a Global Transition

The designation of Australia’s TGA marks the final step in transitioning all agencies previously classified as Stringent Regulatory Authorities (SRAs) into the unified WLA framework. This shift streamlines global regulation under a single, transparent and predictable system used by WHO, nations and international procurement partners.

Australia’s TGA has long served as a reference authority for regulators around the world. Its listing:

• Reinforces global trust in its regulatory decisions

• Supports modern approaches to regulatory convergence

• Enhances reliance frameworks that promote efficiency and mutual recognition

This strengthens global supply chains and provides continuity in regulatory leadership.

Momentum Grows Across the Global Regulatory Community

Several national regulatory bodies have already expressed interest in entering the WLA evaluation process, signalling rising confidence in the system and a growing commitment to strengthening regulatory capacity worldwide.

As the WLA network expands, it helps build more resilient supply chains, accelerates access to high-quality medical products and improves global preparedness for future health crises. The recognition of Australia and Indonesia represents not only national achievements but also an important step toward a more equitable and harmonized global health regulatory environment.