BPOM Clarifies Indonesia–US Trade Agreement Impact on Pharmaceutical Regulation

On February 26, 2026, Indonesia’s National Agency of Drug and Food Control — Badan Pengawas Obat dan Makanan (BPOM) — issued a public clarification addressing media coverage of a reported Indonesia–United States Agreement reciprocal trade arrangement and its potential implications for pharmaceutical regulation.

BPOM stated that the agreement does not alter Indonesia’s regulatory framework for pharmaceutical products. The agency reaffirmed that it remains the sole authority responsible for granting marketing authorization (izin edar) for medicines in Indonesia.

BPOM Retains Full Authority Over Pharmaceutical Marketing Authorization

According to BPOM, all pharmaceutical products must continue to undergo Indonesia’s national drug registration and evaluation process before being approved for distributed. The reported trade arrangement does not introduce automatic approval pathways or bypass existing regulatory requirements.

This means that approvals granted by foreign regulators do not replace BPOM’s review, and all products remain subject to local regulatory oversight.

Regulatory Reliance Supports — But Does Not Replace — Evaluation

BPOM confirmed that it continues to apply regulatory reliance mechanisms as part of its scientific review process. Under this approach, assessments conducted by trusted regulatory authorities such as the United States Food and Drug Administration (US FDA) may be used as supporting references.

However, BPOM emphasized that reliance does not transfer decision-making authority. Final approval decisions remain fully under Indonesia’s jurisdiction.

GMP Inspection Cooperation May Reduce Duplication

BPOM also noted that Good Manufacturing Practice (GMP) inspections conducted by the US FDA for manufacturing facilities located in the United States may be considered during BPOM’s evaluation process.

In many cases, this can reduce the need for additional inspections by BPOM, although the authority retains the right to conduct its own inspections where necessary.

This cooperation is supported by both regulators’ participation in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which promotes harmonized GMP standards and mutual confidence in inspection outcomes.

International Recognition Supports Regulatory Cooperation

BPOM highlighted that both it and the US FDA have been recognized under the World Health Organization’s Listed Authority (WLA) framework, reflecting alignment with international standards for the regulation of pharmaceutical safety, efficacy, and quality.

Such recognition facilitates regulatory cooperation and supports the use of reliance-based approaches without compromising national oversight.

Public Health Safeguards Remain Unchanged

BPOM reiterated that the protection of public health remains its primary mandate. The agency retains full authority to take regulatory action if concerns arise regarding the safety, efficacy, or quality of pharmaceutical products.

Final Thoughts

BPOM’s clarification indicates that, despite ongoing regulatory cooperation between Indonesia and the United States, Indonesia’s pharmaceutical regulatory framework remains unchanged. Marketing authorization decisions, compliance requirements, and regulatory enforcement continue to be governed solely by BPOM.

While reliance mechanisms and international cooperation may improve efficiency, they do not diminish Indonesia’s regulatory independence or oversight of pharmaceutical products.

Cisema supports pharmaceutical companies throughout this process by providing regulatory strategy, submission management, and compliance guidance across Asia’s regulated markets, including Malaysia, Singapore, Vietnam, Indonesia, the Philippines, Thailand, Hong Kong, Taiwan, and China.

For pharmaceutical manufacturers seeking drug registration or market entry in Indonesia, contact Cisema today for expert support with BPOM regulatory submissions, compliance strategy, and pharmaceutical market authorization.

Reference

News of the Indonesia-United States Reciprocal Trade Agreement related to Pharmaceutical Products