Regulatory Filing Fee — NDA/BLA/MAA Submission
Recording the regulatory user fee paid to the FDA (or EMA/other agency) upon filing a new drug application.
| Account Name | Type | Debit ($) | Credit ($) |
|---|---|---|---|
| Regulatory Affairs Expense (R&D) | Expense (+) | 3,200,000.00 | - |
| Cash / Bank | Asset (-) | - | 3,200,000.00 |
💡 Accountant's Note
The FDA PDUFA (Prescription Drug User Fee Act) application fee for a New Drug Application or Biologics License Application is a significant one-time cost expensed at the time of filing. The fee covers the FDA's review costs. In 2024, the NDA/BLA fee was approximately USD 3.2 million. Fee waivers are available for orphan drug and small business applications.
Practitioner & Systems Framework
💻 ERP Architecture
Regulatory filing fees are expensed immediately at the filing date — they are period costs that do not meet the IAS 38 asset recognition criteria. The fee is classified as regulatory affairs expense within R&D. It is paid electronically to the FDA at the time of submission. The fee is non-refundable if the application is withdrawn after acceptance (though partial refund may apply in certain circumstances). Fee waivers for orphan drugs require advance application to the FDA.
⚠️ Audit Flags
Auditors confirm the filing date and verify the fee was paid at the correct PDUFA fee schedule rate for the filing year. Test that the expense is classified as R&D (not selling or administrative). For orphan drug waivers, confirm the waiver was obtained before the filing fee was due. Assess whether any portion of the application fee should be disclosed as a contingent asset (refundable fee) if the application is refused filing.
📄 Required Documentation
NDA/BLA/MAA submission confirmation letter from the regulatory agency, PDUFA fee schedule for the filing year, payment confirmation, orphan drug waiver confirmation (if applicable), regulatory affairs expense account classification, and regulatory milestone disclosure in financial statement notes.
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