Government Explains BPOM's Role in Indonesia-US Reciprocal Trade Agreement
The government has denied that the Indonesia-United States Reciprocal Trade Agreement (ART), signed by both nations on 19 February 2026, will weaken the role of the National Agency of Drug and Food Control (BPOM) in overseeing US-origin products.
The Coordinating Ministry for Economic Affairs stated that BPOM and the US Food and Drug Administration (FDA) already maintain extensive technical cooperation in areas including the harmonisation of product safety standards, the exchange of product safety information, and the supervision of medicines, vaccines, and cosmetics.
Indonesia recognises marketing authorisations issued by the FDA as evidence that a product has met safety, quality, and efficacy standards.
“As is widely known, the FDA is recognised as one of the world’s strictest regulatory bodies for medicines and medical devices,” said Coordinating Minister for Economic Affairs spokesperson Haryo Limanseto in a statement on Sunday (22 February).
“This means that if a product has already undergone a rigorous evaluation process in the United States, Indonesia does not need to repeat the entire testing process from scratch. This is to avoid duplication of the same procedures,” he added.
Although the technical evaluations conducted by the FDA will be accepted as sufficient evidence to meet marketing authorisation requirements in Indonesia, these products must still go through the administrative licensing process in Indonesia and remain under BPOM’s supervision.
Furthermore, Haryo affirmed that should significant safety, efficacy, or quality concerns be identified in the future, Indonesia retains the right to take supervisory action in accordance with its authority.
One of the issues addressed in the Indonesia-US Reciprocal Trade Agreement concerns the marketing of medical devices and pharmaceuticals. This matter is discussed in Annex III: Specific Commitments, Section 1. Tariffs and Quotas, Article 2.5: Medical Devices & Pharmaceuticals.
One of the key provisions in that section stipulates that Indonesia will accept inspection results from the FDA without requiring re-inspection of US products entering Indonesia.
“Indonesia shall not require periodic renewal of marketing authorisations for pharmaceutical products that have obtained marketing authorisation from the United States, unless Indonesia identifies significant safety, efficacy, or quality concerns,” the agreement states.
“Indonesia shall accept the results of Good Manufacturing Practice (GMP) surveillance inspections conducted by the FDA on pharmaceutical manufacturing facilities without requiring further inspection or re-inspection by the relevant Indonesian regulatory authority, provided the following conditions are met: (a) the manufacturing facility is located within the territory of the United States; and (b) the most recent FDA inspection report provided by the facility is classified as no action indicated, demonstrating the absence of unacceptable conditions or practices.”