WHO lists Australia and Indonesia as Medical Products Regulatory Authorities
The World Health Organization (WHO) has recognized the medical products regulatory authorities of Australia and Indonesia as WHO Listed Authorities after they met the organization’s highest international standards.
Australia’s Therapeutic Goods Administration and the Indonesian Food and Drug Authority now join the WLA network, which includes 41 authorities from 39 countries. WHO Assistant Director-General for Health Systems, Access and Data Yukiko Nakatani said the expanded network supports a more inclusive and globally connected regulatory system that improves access to safe, effective and quality health products worldwide.
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The WLA framework supports regulatory reliance by allowing regulators, international agencies and procurement bodies to use the decisions of listed authorities. This approach reduces duplicated reviews, helps ease supply constraints and speeds access to medicines and vaccines, including during health emergencies.
WHO grants WLA status through a voluntary and science-based assessment using internationally agreed standards. Regulatory authorities undergo detailed technical evaluations to show reliable oversight across specific areas of medical product regulation.
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Indonesia’s Food and Drug Authority is the first standalone regulator from a middle-income country to achieve WLA status. WHO said the designation demonstrates that advanced regulatory capacity can be achieved across different resource settings and may encourage other low- and middle-income countries to pursue similar recognition.
With Australia’s inclusion, all authorities previously classified as stringent regulatory authorities have completed the transition into the WLA framework. WHO said other national regulators have already expressed interest in entering the process, indicating growing uptake of the system.
Source: WHO
Category: Community
