BPOM to Maintain Oversight of American Products Despite Reciprocal Trade Deal
The government has affirmed that the reciprocal trade agreement between Indonesia and the United States, signed on 19 February 2026, will not weaken the role of the National Agency of Drug and Food Control (BPOM) in overseeing American products.
Spokesperson for the Coordinating Ministry for Economic Affairs Haryo Limanseto said BPOM and the US Food and Drug Administration (FDA) have long maintained 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 products have met safety, quality and efficacy standards. Haryo noted that the FDA is globally recognised as one of the most rigorous regulatory bodies for medicines and medical devices.
“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 process,” Haryo said, as quoted from a written statement on Monday, 23 February 2026.
Nevertheless, Haryo stressed that American products must still go through Indonesia’s administrative licensing process and remain under BPOM supervision. The technical evaluations conducted by the FDA will be recognised as sufficient evidence to fulfil marketing authorisation requirements in Indonesia. “If safety, efficacy or quality issues of significance are subsequently identified, Indonesia retains the right to take supervisory measures within its authority,” Haryo said.
President Prabowo Subianto and President Donald Trump officially signed the reciprocal trade agreement in Washington DC on Thursday, 19 February 2026, local time. The bilateral meeting between the two heads of state lasted approximately 30 minutes following the Board of Peace proceedings. The signing also formalised the imposition of a 19 per cent tariff on Indonesian products exported to the United States.
One of the key agreements concerns the marketing of medical devices and pharmaceuticals. This commitment is set out in Annex III: Specific Commitments, Section 2: Tariffs and Quotas, under Article 2.5: Medical Devices and Pharmaceuticals.
Under the agreement, Indonesia will accept approvals or marketing authorisations issued by the FDA as sufficient evidence that medical devices manufactured in the United States meet Indonesian requirements for marketing approval. Indonesia will also not require marketing approval for low-risk medical devices where such approval or authorisation is not required by the FDA.
Furthermore, a fifth provision states that Indonesia will not require periodic renewal of marketing authorisations for pharmaceutical products that have received US marketing approval, unless Indonesia identifies significant safety, efficacy or quality concerns.
“Indonesia will accept the results of FDA good manufacturing practice surveillance inspections of pharmaceutical manufacturing facilities without requiring additional inspections or re-inspections by the relevant Indonesian regulatory authority, provided the following conditions are met: (a) the manufacturing facility is located within US territory; 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,” reads the final provision of the article.