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View all search resultsBy securing the WHO’s elite global benchmark, Indonesia has transformed regulatory trust from a technical achievement into a strategic asset, proving that middle-income nations can lead the world in global health security.
Safety assurance: A Food and Drug Monitoring Agency (BPOM) employee tests food samples on Dec. 23, 2025, during an inspection at Anyar Market in Tangerang, Banten. The inspection was carried out to ensure food safety, maintain price stability and secure food supplies ahead of Christmas and the 2026 New Year. (Antara/Putra M. Akbar)
head of its 25th anniversary on Jan. 31, the Food and Drug Monitoring Agency (BPOM) achieved a major milestone: official recognition as a World Health Organization- listed Authority (WLA) for its vaccine regulatory system. Announced by the WHO on Dec. 21, 2025, this recognition represents more than a mere institutional achievement; it is a clear affirmation of international trust in Indonesia’s regulatory framework and governance.
Only a limited number of regulatory authorities worldwide have attained WLA status. Indonesia is the first middle-income country with a standalone regulatory authority to achieve this recognition, joining an elite group of 38 predominantly developed nations, including the United States, the United Kingdom and Australia. This status confirms that BPOM’s regulatory decisions meet global standards and can be relied upon far beyond national borders.
The WLA framework serves as the WHO’s global benchmark for regulatory excellence. It is a public registry of authorities that have undergone rigorous evaluation and demonstrated consistent performance in ensuring the quality, safety and efficacy of vaccines. By promoting transparency, the harmonization of standards and regulatory reliance, the framework allows countries to trust one another’s decisions and reduces unnecessary duplication. In an increasingly interconnected world, such trust is essential to global health security.
BPOM’s path to becoming a WLA was the result of sustained reform rather than a singular accomplishment. The journey began in 2018, when BPOM achieved WHO Maturity Level 3 for vaccines, indicating a functional regulatory system. From that point, the focus shifted toward reaching Maturity Level 4, which reflects a stable, integrated and advanced authority.
This transition required a fundamental shift from administrative compliance toward evidence-based governance. Over several years, BPOM strengthened core regulatory functions, including clinical trial oversight, laboratory testing, lot release and post-market surveillance. Throughout this process, three principles remained non-negotiable: independence, transparency and scientific integrity.
The evaluation process itself was extensive. BPOM conducted a comprehensive self-assessment using the WHO Global Benchmarking Tool, followed by peer reviews and in-depth assessments by international experts. The process culminated in an evaluation by the WHO Technical Advisory Group on Listed Authorities, an independent body that ensures only regulators with consistent, high-level performance are granted WLA status. Meeting these standards demonstrated that BPOM’s decisions are grounded in robust science and strong institutional governance.
Beyond national benefits, Indonesia’s recognition carries global significance. It sends a clear signal that regulatory excellence is not limited to high-income countries; strong, credible regulatory systems can be built in diverse resource settings and trusted globally. In this sense, BPOM’s achievement contributes to a more inclusive and resilient global regulatory landscape.
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