February 23, 2026 | 01:50 pm
TEMPO.CO, Jakarta - The government has emphasized that the reciprocal trade agreement between Indonesia and the United States, signed on February 19, 2026, will not undermine the role of the Indonesian Food and Drug Monitoring Agency (BPOM) in overseeing American goods.
Coordinating Ministry for the Economy spokesperson Haryo Limanseto stated that the BPOM and the U.S. Food and Drug Administration (FDA) have collaborated extensively on harmonizing product safety standards, exchanging product safety information, and overseeing drugs, vaccines, and cosmetics.
Indonesia recognizes the FDA's issuance of marketing authorization as evidence that the products have met safety, quality, and effectiveness standards. Haryo explained that the FDA is known for its strict global standards for monitoring drugs and medical devices.
He added, "This means that if a product has undergone rigorous evaluation in the United States, Indonesia does not need to repeat the entire testing process. This is to avoid duplicating the same process."
However, Haryo emphasized that American goods still have to go through the licensing administration process in Indonesia and be under the supervision of BPOM. The technical evaluations conducted by the FDA will be recognized as sufficient evidence to meet marketing authorization requirements in Indonesia. "If safety, effectiveness, or significant quality issues are found later on, Indonesia can still take regulatory measures as authorized," Haryo said.
President Prabowo Subianto and President Donald Trump officially signed the reciprocal trade agreement in Washington DC on Thursday, February 19, 2026. The bilateral meeting between the two heads of state took place about 30 minutes after the Board of Peace activities. The signing also formalized the imposition of a 19 percent tariff on Indonesian products on the U.S.
One of the agreements concerns the marketing of medical devices and pharmaceuticals. This agreement was discussed in Annex III: Specific Commitments, Section 1. Tariffs and Quotas, and is included in Article 2.5: Medical Devices & Pharmaceuticals.
Under this agreement, Indonesia will accept FDA-issued marketing approvals as sufficient evidence that medical devices produced in the U.S. meet Indonesia's marketing approval requirements. Indonesia will also not require marketing approval for low-risk medical devices, for which FDA approval is not needed.
Meanwhile, in the fifth point, it states that Indonesia will not require periodic marketing approval extensions for pharmaceutical products that have already been approved by the U.S., unless Indonesia identifies significant issues regarding the products' safety, effectiveness, or quality.
"Indonesia shall accept the results of an FDA good manufacturing practice surveillance inspection of a manufacturing facility for pharmaceutical products without further need for an inspection or reinspection performed by Indonesia’s relevant regulatory authorities when the following conditions apply: (a) the manufacturing facility is within the territory of the United States; and (b) the most recent FDA inspection report, as provided by the facility, is classified as no action indicated, demonstrating no objectionable conditions or practices." That is the last point in the article.
Read: Prabowo Orders Review of US Court Ruling on Trump's Tariffs
Click here to get the latest news updates from Tempo on Google News
Some US Goods Exempt from Indonesia's Local Content Rules
4 jam lalu
Indonesia's Coordinating Ministry for the Economy stated that the domestic component level (TKDN) policy does not bind all U.S. goods.
Indonesia Hit by Trump's 19% Tariff as of August 7, Minister Says Talks Still Ongoing
7 Agustus 2025
The Minister of Trade stated that Indonesia is still in the process of negotiating for the US to lower tariffs and exempt import duties on a number of commodities.
KPK to Auction Confiscated Assets in June 2025
28 Mei 2025
The KPK will auction off goods confiscated from 32 corruption cases they have handled
Indonesian Govt Discloses Uncertified Chinese Goods Circulating on TikTok
22 Mei 2025
The Indonesian Trade Ministry said that it confiscated Chinese goods after conducting surveillance and observation on social media, including TikTok
Prabowo's Move to Scrap Import Quotas: What's Behind the Decision?
9 April 2025
The removal of import quotas is part of the government's efforts to provide convenience for business actors and streamline bureaucracy.
Tariffs: What Are They and How Do Tariffs Affect the Economy
18 Maret 2025
How do tariffs affect the economy? There are multiple layers consumers need to know before diving deeper. See the discussion here.
Director General of Taxes Says 12 Percent VAT Imposed on Some Goods and Services
22 Desember 2024
The Indonesian govt has finally acknowledged that the increase in Value Added Tax (VAT) next year will not be selectively applied only to luxury goods
