The US Food and Drug Administration (FDA) will start accepting applications for the new PreCheck scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US, commissioner Marty Makary confirmed.
The PreCheck programme, was unveiled in June 2025. As per an update on the programme’s roadmap on 21 January, the FDA said it would begin accepting applications on 1 February.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Concurring with the timeline via a post on X, Makary stated: “The FDA PreCheck program — which is designed to accelerate domestic manufacturing — will start accepting applications next week! This is a national security issue we are not ignoring.”
The PreCheck scheme is part of a strategy by the Trump administration to reduce overreliance on imports.
The first stage, called the Facility Readiness phase, will allow more frequent communication with the FDA to discuss facility design, construction, and pre-production. Companies will be encouraged to provide information on their proposed facilities, such as site operations layouts and quality control elements. The Application Submission phase, the second portion of the scheme, focuses on chemistry, manufacturing, and controls.
Apart from knock-on effects from pricing agreements between the White House and drug companies, the PreCheck programme is the first FDA policy directed at bolstering US pharma manufacturing.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe FDA said it will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026.
The agency added that these will be made based on a facility’s “overall alignment with national priorities.” This includes products intended for the US market or facilities that demonstrate innovation in development.
Diderik Stadig, sector economist for TMT and Healthcare at ING, told Pharmaceutical Technology at the time of the programme’s launch that it looked “promising” on paper, offering a way to streamline US manufacturing and drug approvals.
“However, with the FDA facing budget cuts, its long-term impact remains to be seen,” said Stadig. “The press release also highlights a goal of reducing dependence on foreign drugs and APIs but achieving that will require a far more concerted effort, particularly in the area of generics.”
More than half of pharmaceuticals distributed in the US are manufactured overseas. The country is particularly exposed in the active pharmaceutical ingredients (APIs) supply chain. Of the manufacturers that produce APIs used in FDA-approved products, only 11% are based in the US.
