AHEAD of its 25th anniversary on Jan 31, the Food and Drug Monitoring Agency (BPOM) achieved a major milestone: official recognition as a World Health Organisation (WHO) – 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 harmonisation 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.
WLA recognition reinforces BPOM’s role not only as a regulator but also as an enabler.
This trust carries particular weight as global health risks increase, supply chains remain fragile and countries face mounting pressure to ensure safe, effective and equitable access to medical products.
Regulatory credibility is no longer a purely technical matter; it has become a strategic asset that underpins public health, innovation and economic competitiveness.
In today’s policy environment, regulatory trust functions as a global public good. It strengthens policy credibility and amplifies Indonesia’s voice in global health diplomacy.
Moreover, a credible regulator serves as an institutional bridge connecting academia, industry and government.
For academia, internationally recognised regulatory standards enhance the credibility of Indonesian research and clinical trials, opening greater opportunities for global collaboration.
For industry, regulatory trust reduces risk and uncertainty.
Predictable and transparent regulatory pathways encourage investment in research and development, technology transfer and high-value manufacturing.
The impact of WLA recognition is especially significant for Indonesia’s pharmaceutical and vaccine industries as they compete in international markets.
Products regulated by a globally recognised authority face fewer barriers and gain faster acceptance.
This positions Indonesian manufacturers as reliable partners in global supply chains and supports Indonesia’s ambition to move from scale toward sophistication.
Furthermore, by recognising authorities like BPOM, the WHO is building a decentralised network of trust that supports regional manufacturing and strengthens global resilience.
Decisions made by BPOM can now be relied upon by other regulators and international procurement bodies, shortening approval timelines.
Indonesia is thus well-positioned to support peer regulators in the Global South by sharing expertise and serving as a credible reference. WLA recognition also brings heightened responsibility. BPOM will be judged not only by its high standards but also by its ability to maintain them consistently over time.
One of the most significant risks any trusted regulator faces is regulatory capture. As engagement with industry and innovation ecosystems increases, collaboration must never compromise impartiality. — The Jakarta Post/ANN
Taruna Ikrar is head of the Food and Drug Monitoring Agency. The views expressed here are the writer’s own.
