The FDA (U.S. Food and Drug Administration) officially started its PreCheck pilot program and is now accepting applications from companies that want to join. However, the FDA decided not to allow existing pharmaceutical facilities to take part in the program, despite requests from the industry.
The program was created to help encourage pharmaceutical manufacturing in the U.S. as part of the Trump Administration's goal. The FDA plans to select new pharmaceutical manufacturing facilities and start the PreCheck activities this year.
The FDA said it used a lot of feedback from the industry to design the program. The industry supported having early involvement in facility development and simpler documentation. However, the FDA did not agree to include existing facilities in the program.
According to the eligibility rules, the FDA is looking for new manufacturing facilities that are either already being built or are in the planning stages to produce human drugs or biological products.
Sponsors will need to agree to submit an original New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), or an application for drug substance (DS) for the new manufacturing facility. For small molecule APIs, they must also submit a Type II DMF.
Companies must also agree to actively produce products in the facility for at least three years after the FDA approves it.
The pilot program has two phases:
- Phase 1 (Facility Readiness): Manufacturers chosen for the program can get early advice from the FDA before their facility starts operating. This phase includes reviews of the facility before it begins production and helps with using a facility-specific Drug Master File (DMF) to speed up the process of evaluating the facility.
- Phase 2 (Application Submission): In this phase, the FDA as well as the manufacturers will work together to review and finalize the drug application. They will meet to discuss any issues and make sure the manufacturing details in the application are ready for approval.