FDA: PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing
The U.S. Food and Drug Administration has started the “PreCheck Pilot Program”, a strategic initiative to strengthen the U.S. pharmaceutical supply chain by facilitating domestic manufacturing.
The program addresses the increasing reliance on overseas production, with more than half of pharmaceuticals supplied in the U.S. manufactured abroad and only about 11% of API manufacturers located domestically. In response to Executive Order 14293, FDA aims to reduce regulatory barriers and streamline review and inspection processes for new manufacturing facilities.
The pilot follows a two-phase approach:
- Phase 1 (Facility Readiness): Early FDA engagement during facility development, including technical advice, pre-operational reviews, and the use of facility-specific Drug Master Files.
- Phase 2 (Application Submission): Continued interaction to resolve issues and accelerate the assessment of manufacturing information and inspections.
Phase I will begin in 2026 with selected companies developing new facilities for finished dosage forms or APIs.
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