FDA Looks East—Here’s What Industry Needs to Know

If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade.  After consolidating from 13 foreign offices down to 8 between 2012 and 2014—and losing its Pretoria, South Africa office in 2015—the Agency is now back in expansion mode.  And the latest moves are worth paying close attention to if your products are manufactured or sourced overseas.  For a general overview of FDA’s purpose behind and process for choosing foreign offices, see the Agency’s 2012 Report to Congress on the FDA Foreign Offices.  The Government Accountability Office (GAO) has also issued several reports related to improvements needed at FDA’s foreign offices to support inspections of foreign food (2015) and drug (2016 and 2022) facilities.

What FDA is Proposing

FDA’s FY2027 budget request includes an additional $2.5 million and five new full-time equivalent employees dedicated to opening two new foreign offices—one in Hanoi, Vietnam, and one in Tokyo, Japan.  These offices are expected to conduct both food and medical product inspections, and the Agency frames the investment explicitly around strengthening global competitiveness and inspection capabilities.

These moves aren’t coming out of nowhere.  Both offices were already funded in the FY2026 FDA appropriations bill, and the Senate’s accompanying joint explanatory statement specifically called for the agency to build a permanent presence in East Asia—including Tokyo and Hanoi—to conduct traditional and unannounced inspections.  Senators also signaled a desire for FDA to beef up regulatory control over devices, drugs, and aquaculture products coming out of the region.  The FY2027 request is essentially the next step in turning that congressional aspiration into reality.  Separately, the FY2027 budget request also includes $9 million to “increase foreign inspection capacity.”

Why These Locations?

Tokyo might raise some eyebrows.  Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is widely regarded as one of the most sophisticated drug regulators in the world—on par with FDA and the European Medicines Agency.  So why plant a flag there?

A few reasons are worth considering or at least speculating upon.  First, Tokyo is geographically well-positioned as a hub for broader regional access across Asia.  Second, there’s a growing U.S.-Japan regulatory collaboration story here—PMDA opened its own office in Washington, D.C. in 2024 to deepen ties with U.S. regulators and help companies navigate its market.  An FDA presence in Tokyo could reciprocate and strengthen that relationship.

Hanoi, in our opinion, is a more straightforward choice.  Vietnam has become a significant and growing source of drugs and other products imported into the United States (see here), and closer on-the-ground inspection capacity there makes clear operational sense.  Imports of FDA-regulated products from Vietnam have increased significantly in recent years.  In FY2015 there were just shy of 96,000 lines of product imported from Vietnam, but by FY2025 that number had increased tenfold to over 961,000 lines.  What is being imported from Vietnam has also changed significantly:  in FY2015 the vast majority (~70%) of those imports were human foods, but, by FY2025, 60% of those imports were medical devices (see FDA Data Dashboard, Imports Summary).  The Senate’s specific mention of aquaculture products—a major Vietnamese export—signals that Congress also has that supply chain squarely in its sights.

Not As Simple As Writing a Check

It’s worth noting that opening foreign offices involves more than budgeting the funds.  As we’ve covered previously, FDA has long struggled with vacancies in its existing foreign offices.  As described in the 2022 GAO Report detailing improvements needed to FDA’s foreign drug facility inspection, FDA has had difficulty recruiting qualified staff to foreign offices and, once a qualified candidate is selected, it can take an additional 9-12 months to complete the “security and medical clearances and other prerequisites” needed to work overseas.  FDA learned this lesson the hard way in 2013 and 2014 when the Agency spent months waiting on visas just to staff its China office.

So, while the funding request and congressional support are positive signals, companies shouldn’t expect these offices to be operational overnight.

The Bigger Picture:  FDA’s Expanding Foreign Footprint

The Tokyo and Hanoi offices are part of a broader pattern of FDA re-engagement internationally.  The Agency currently operates seven foreign offices—in Mexico, Costa Rica, Chile, Belgium, Rwanda, India, and China—and, as evidenced by this blog post and other indicators, is actively working to add more.  The Belgian office includes a staffer embedded with the European Medicines Agency in the Netherlands and the Rwanda location in the African Medicines Agency Liaison Office.

A Middle East office is also on the way.  The Give Kids A Chance Act (see our previous post here), enacted earlier this year as part of appropriations legislation, mandated that FDA establish a presence in a country that signed the Abraham Accords—which includes Israel, the UAE, Bahrain, Morocco, and Sudan—by January 2028.  Agency officials are still conducting consultations to determine the specific location, and it’s unclear whether this timeline remains on track.

On the other hand, a planned office in Brasilia, Brazil appears to have stalled.  FDA had signaled interest in a Brazil office as recently as 2024, but it’s no longer listed among the Agency’s active foreign office plans.

What This Means for Industry

For companies with manufacturing operations or supply chains in East Asia—particularly in Vietnam and Japan—the regulatory trajectory is clear:  FDA intends to have a more persistent, on-the-ground presence in your backyard.  That means greater capacity for unannounced inspections, faster response to emerging compliance issues, and less reliance on headquarters-managed oversight from the White Oak facility in Maryland.

If, for example, your supply chain runs through Vietnam or involves Japanese contract manufacturers, now is a good time to review your inspection readiness, as well as the readiness of your CMOs and critical suppliers.  FDA’s foreign offices have historically served as force multipliers for the Agency’s inspection program, and there’s no reason to expect the Hanoi and Tokyo outposts to be any different.  HPM regularly provides inspection readiness training to foreign and domestic manufacturers and can assist with CMO Quality Agreements to ensure responsibilities are clearly allocated in advance of an inspection.

The bottom line:  FDA is investing in its ability to see what’s happening at the source—and that investment is coming to East Asia.