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The Therapeutic Goods Administration (TGA) has received an internationally recognised designation from the World Health Organization (WHO), reaffirming TGA’s role as a trusted global medicines regulator operating to ensure medicines and vaccines meet the highest international standards for quality, safety and efficacy.
Implemented in 2022, the WHO Listed Authority (WLA) initiative provides a transparent, evidence-based pathway to identify national regulatory authorities that demonstrate advanced regulatory capability. All those medicines regulators designated as a WLA maintain high standards in the quality, safety and efficacy of medicines and vaccines, serving as a benchmark for other countries.
To attain WLA status, a regulatory authority undertakes an extensive and rigorous performance evaluation led by a science-based, data-driven process established under commonly agreed international standards.
“The WLA designation is a significant milestone for Australia, clearly demonstrating our commitment to regulatory excellence and public health. It is a testament to the dedication and expertise of our organisation and people,” said Professor Anthony Lawler, Head of the TGA.
“For Australians, this important recognition from the WHO reinforces that the TGA’s decisions are evidence-based. Australians can trust in using the medicines and vaccines approved by the TGA. This is especially important in an era of widespread misinformation and disinformation aimed at science, medical products and regulatory authorities,” Professor Lawler said.
“WLA regulators also play a critical role in improving global health by enabling others to rely on and have trust in the decisions we make. Being recognised as a WLA means that other national regulators, global health partners, medicines procurement agencies such as the Global Fund and UNICEF, and other countries in our region can continue to confidently rely on the TGA’s decisions to support timely access to safe and effective medical products.”
“The TGA will also look to apply insights from the WLA assessment to further strengthen our processes, enhance transparency, and deepen collaboration with stakeholders. Working more closely with Australia’s states and territories will be a key priority.”
As a WLA, the TGA joins a select group of high-performing regulators – including the European Medicines Agency (EMA) and Health Canada – who are all globally acknowledged for meeting stringent international benchmarks.
The WLA designation builds on the TGA’s legacy as a previously recognised Stringent Regulatory Authority (SRA) by the WHO, and strengthens the TGA’s role in global health initiatives to enable:
- International trust and reliance: Other countries and WHO programs can leverage the TGA’s assessments to expedite approvals, with the TGA currently seen as a trusted regulator supporting capacity building across the Indo-Pacific region.
- Regulatory convergence: Supports global alignment and strengthens cooperation among international regulators, with the TGA actively partnering with counterparts worldwide.
- Enhanced public health impact: Recognition contributes to faster access to quality-assured medicines and vaccines globally, which is especially important in low resource settings and during major global health emergencies.
Speaking about the WLA program, WHO Director-General Dr Tedros Adhanom Ghebreyesus has emphasised that “strong and trusted regulators help ensure that people everywhere have access to safe, effective, and high-quality medical products”.
WHO Announcement: Australia and Indonesia achieve WHO Listed Authority status in medical products regulation
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