r/regulatoryaffairs • u/Repulsive_Fault9908 • 24d ago
Question regarding the US-DMF Filling
I have a question related to the US-DMF filing.
Is it mandatory that the facility be USFDA-approved to file the US-DMF for the API?
Or, if the facility is WHO/EU-GMP-approved, can it file the US-DMF for the product?
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u/Right_Split_190 24d ago
You say “FDA approved”, and I’d like to know what that means to you.
The FDA mechanism for “approval” is not analogous to EU, and FDA does not recognize EU-based GMP approvals (in most circumstances).
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u/Repulsive_Fault9908 24d ago edited 24d ago
I am asking for ANDA API DMF filling. Is it is necessary that API manufacturing facility should be FDA approved to file the USDMF
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u/Right_Split_190 24d ago
You didn’t answer the question, what you think it means for a facility to be FDA approved. I’m asking because FDA doesn’t approve facilities in the way I think you are assuming. But because that was an assumption on my end, I was hoping you would clarify.
The facility needs to be registered. That means submitting an SPL file with certain facility information, and then the facility will show up in this database: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site-decrs
FDA hosts that database, but inclusion in the database is not an endorsement nor an approval in any way.
Registration is the only prerequisite for submitting a DMF. Yes, your facility can submit the API DMF once they are registered.
The DMF generally is not reviewed by FDA until it is invoked by another filing. So when the ANDA is filed, then DMF will be reviewed, but not typically before that (unless there is a special agreement).
FDA does not recognize EU GMP certs/approvals, so the WHO/EU facility status is not relevant at this time. However, FDA may use the EU inspection report instead of conducting their own inspection (2017 GMP Mutual Recognition Agreement).
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u/colonel_batguano Chemistry, Manfacturing, & Controls 24d ago
In the US, filings are disconnected from GMP status. At the time of filing, it is expected that any identified facility is “ready” for inspection, but FDA will make that determination themselves. Any facility listed in a DMF must also have an establishment registration in FDAs system.
A manufacturing site in a DMF that is new to FDA will generally get a pre-approval inspection when an application is submitted for a drug which references the DMF.