On January 24, 2025, the Food and Drug Administration (FDA) of the Philippines announced the temporary suspension of pre-assessment fees for specific applications, as outlined in FDA Advisory No. 2025-0076. This decision aims to address challenges in implementing Administrative Order (AO) No. 2024-0016, which establishes a new schedule of fees and charges.
Key Highlights
Temporary Suspension of Pre-Assessment Fees
- Effective January 12, 2025, the collection of pre-assessment fees is suspended until further notice.
- The suspension applies to applications related to specific licensing, product notifications, registrations, and permits.
- Applications submitted before January 12, 2025, will be processed without requiring a pre-assessment fee.
Exceptions & Continuing Fees
- The pre-assessment fee remains applicable to Licensing Applications submitted via the FDA’s e-services platform under the pilot implementation of AO No. 2024-0015.
- This includes applications from:
- Drug distributors and traders
- Pharmaceutical outlets
- Contract Research Organizations (CROs)
- Sponsors
Processing of Pending Applications
- For pending drug and medical device product applications submitted before January 12, 2025 (including re-applications), previous fee structures under AO No. 50, s.2001 will apply.
- If a re-application results in a Letter of Disapproval (LOD), the timelines established in earlier guidelines will be followed.
Additional Resources
For further details, refer to the official FDA advisory:
https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0076.pdf
https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0076.pdf
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