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Indonesia's Food and Drug Administration (FDA) has officially become a listed authority by the World Health Organization and is preparing to expand global cooperation.
2026-03-19
Kuala Lumpur — Taruna Ikrar, Director General of the Indonesian Food and Drug Administration (BPOM), spoke at the 14th Annual CIRS Regulators' Forum on Tuesday, March 3, 2026, at the InterContinental Kuala Lumpur, Malaysia. The forum was hosted by the Centre for Innovation in Regulatory Science (CIRS). BPOM's participation in this global regulators' forum has become even more strategic following its official listing as a vaccine by the World Health Organization (WHO) on December 21, 2025, under the WHO-Listed Authority (WLA).
CIRS is an independent research organization that provides a platform for policy leaders from government regulatory agencies, health technology assessment (HTA) agencies, the pharmaceutical industry, patient organizations, and the healthcare academic community to discuss issues. This year's 14th annual forum, themed "Making Reliance Work: Practical Approaches and Tools for Effective Regulatory Collaboration," focuses on strengthening cross-border cooperation through a regulatory reliance approach.
This year's CIRS Forum was chaired by John Lim of the Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School, Singapore. The event also attracted numerous authoritative and international organizations, including the National Pharmaceutical Regulatory Agency of Malaysia, the Health Sciences Authority of Singapore, the Department of Health Australia, the University of Melbourne, the Food and Drug Administration of the Philippines, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency Japan.
Regulatory dependence is a collaborative approach between drug and food regulatory agencies, where one agency, when making national-level decisions, references assessments, reports, or decisions made by other credible regulatory agencies (reference agencies) without compromising its independence or principles of prudence. At the forum, the BPOM Director delivered a report entitled “Facilitating Future Dependency Implementation: The Importance of Assessment Reports and Information Sharing for Achieving Dependency – Insights from Dependency Agencies on Their Approaches, Challenges, and Opportunities to Leverage Reference Agency Outputs.”
In his report, the BPOM Director emphasized that the transparency of assessment reports and structured information-sharing mechanisms are the foundation for the successful implementation of dependency assessments. He pointed out that this approach not only aims to improve the efficiency of regulatory processes but is also part of the global community's shared responsibility to ensure that the public has faster access to safe, effective, and high-quality medicines.
He outlined several advantages of implementing a dependency system, including improved efficiency in the registration process. As of 2025, BPOM had approved 191 products through this mechanism, covering important therapies such as oncology products, vaccines, and other innovative medicines. Data shows a significant increase in the number of dependency products between 2019 and 2021, particularly in 2020. Over time, the average assessment time has continued to improve, decreasing from over 100 days to approximately 90 days in 2022–2023.
Starting in August 2025, BPOM accelerated its dependency assessment timeline from 120 working days to 90 working days. The impact was evident in 2025, with the average assessment time decreasing again to approximately 79 days, while the number of approved products increased. This demonstrates that efficiency improvements were accompanied by increased processing capacity.
On the other hand, the BPOM Director also acknowledged several challenges in implementing dependency, including the need to build trust in the assessment results of other regulatory agencies, differences in wording and indications among reference countries, and the necessity to ensure consistency between documentation and submissions from reference countries, including in the CMC (Chemistry, Manufacturing, and Quality Control) aspect. To address these challenges, BPOM's strategies include using complete assessment reports (unredacted), mobilizing national drug review committees, implementing joint assessments, and strengthening document review capabilities and procedural coordination.
BPOM's previous WLA status in the vaccine field covers five functions: registration and marketing authorization, facility authorization, regulatory inspection, laboratory testing, and batch release. BPOM becomes one of ten regulatory agencies globally to have achieved this status, and the first independent regulatory agency in a developing country to do so. The BPOM Director General stated that Indonesia is ready to cooperate with other WLA holders on the implementation of regulatory dependencies based on common agreements.
At the end of the report, BPOM Director General Taruna Iklar reiterated his agency's commitment to public protection. "My role at BPOM is that every permit and decision I issue is a step toward protecting human life," he stated, emphasizing that every regulatory decision is part of an effort to protect human life and public health. (HM-Hendriq)