US FDA unveils PreCheck programme to bolster domestic drug manufacturing

The US Food and Drug Administration (FDA) has announced a new initiative aimed at strengthening America's pharmaceutical supply chain through increased regulatory predictability and streamlined processes for constructing manufacturing facilities on US soil.

The FDA PreCheck programme, revealed on 7 August 2025, was developed in response to Executive Order 14293, ‘Regulatory Relief to Promote Domestic Production of Critical Medicines,’ which directs the agency to streamline review processes for domestic pharmaceutical manufacturing whilst eliminating unnecessary regulatory requirements.

According to the FDA, more than half of pharmaceuticals distributed in the US are currently manufactured overseas, with only 11% of active pharmaceutical ingredient manufacturers located domestically. The new programme introduces an innovative two-phase approach to facilitate the establishment of new manufacturing facilities within the United States.

The first phase provides manufacturers with more frequent FDA communication during critical stages such as facility design, construction and pre-production. The second phase focuses on streamlining development of the chemistry, manufacturing and controls section of drug applications through pre-application meetings and early feedback.

To gather industry input on the initiative, the FDA will host a public meeting titled "Onshoring Manufacturing of Drugs and Biological Products" on 30 September 2025, from 9:00 AM to 4:00 PM at the FDA White Oak Campus in Silver Spring, Maryland. Virtual participation will also be available. The meeting will feature a presentation of the FDA PreCheck draft framework, stakeholder discussions on framework strengths and opportunities, and exploration of additional considerations to overcome current onshoring challenges relevant to FDA authority.

The agency is actively seeking input on the proposal, as well as other ideas to incentivise or strengthen pharmaceutical manufacturing in the US, encouraging stakeholders to provide specific rationale and basis for their comments to help shape the final implementation of this significant regulatory initiative.

Source:

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing [Accessed August 8, 2025] https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing