FDA Pre-Check Program
- Date
- April 24, 2026
- Category
US Regulations
- Description
On 7 August 2025 the FDA announced a new Pre-Check Programme for manufacturing facilities. This programme was developed in response to Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines," which directs FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, while maximising review timeliness and predictability. The Pre-Check programme introduces an innovative two-phase approach to facilitate new US drug manufacturing facilities. Further detail regarding this programme was published on 10 April 2026, see https://www.fda.gov/industry/fda-precheck-pilot-program/precheck-pilot-program-structure.
The figure below provides a high-level overview of Phase 1 and Phase 2 of the Pre-Check Pilot Programme.
Phase 1 is Facility Readiness provides manufacturers early engagement and support for new pharmaceutical manufacturing facilities through Pre-Operational Reviews (POR) that assess facility design and construction, equipment design and qualification, and Pharmaceutical Quality System (PQS) design to achieve facility readiness and facilitate development of the Type V Drug Master File (DMF) used to support Phase 2. The POR process is illustrated below:
Engagements throughout the POR may occur through teleconferences, email correspondence, etc. and may also include remote site assessment(s) and site visit(s) as appropriate.
Phase 2 is the Application Submission that provides structured pre-submission engagements with the aim to support expedited facility evaluation and enable earlier inspection timelines in the review cycle.