The US Food and Drug Administration (FDA) has opened applications for its PreCheck Pilot Program, a scheme designed to give domestic pharmaceutical manufacturers early regulatory guidance during the development of new facilities.
The pilot was first launched in August 2025 and the deadline to submit an application is March 1.
The PreCheck Pilot Program is aimed at reducing regulatory uncertainty for new manufacturing facilities producing human drugs or biologics in the US.
By engaging manufacturers before product submission, the FDA intends to provide technical advice on facility design, quality systems, and operational readiness.
The program is open only to new facilities, rather than expansions of existing plants, that align with US priorities for critical medicines and domestic supply security.
What is the process for the application?
The pilot operates in two phases:
- Facility Readiness Phase: Manufacturers submit technical details, including facility design and quality systems, for early review. The FDA provides guidance to address potential regulatory issues before operations begin.
- Application Submission Phase: Building on Phase 1, participants can engage in pre-submission meetings and inspections linked to specific product applications, helping to streamline the formal review process.
How applicants are evaluated
Applicants are evaluated based on several criteria:
- Production of medicines considered critical to US supply
- Stage of development, with preference for pre-operational facilities
- Projected timeline to commercial production
- Innovative approaches to facility design and manufacturing
Selected facilities will form an initial cohort for engagement with the FDA throughout 2026.
Application Timeline
Manufacturers wishing to participate must submit a request by 1 March.
The FDA will review submissions, request additional details from selected applicants, and make final cohort selections later in the year.
Why launch the precheck pilot program?
The PreCheck Pilot Program provides an opportunity for US pharmaceutical manufacturers to gain early regulatory feedback, potentially reducing delays during facility development and improving predictability in the approval process.
The initiative supports broader efforts to strengthen domestic pharmaceutical manufacturing and enhance the resilience of US drug supply chains.