The Philippine Department of Health (DOH) has issued Department Circular (DC) No. 2025-0574, further extending the suspension of the implementation of Administrative Order (AO) No. 2024-0016, which outlines the revised schedule of fees and charges of the Food and Drug Administration (FDA).
The newly released circular continues the temporary halt on the implementation of the updated FDA fee structure to allow additional time for review, internal preparation, and refinement of the revised fee schedule.
Read the full issuance: [Read Here]
Purpose of the Department Circular
- To provide an additional suspension period prior to the enforcement of the revised FDA fees under AO No. 2024-0016.
- To allow the FDA to complete a comprehensive review of the updated fee schedule.
- To provide sufficient time for internal operational adjustments necessary for effective implementation.
- To ensure fairness and preparedness among stakeholders before the revised fees take effect.
Key Highlights
Previous Suspension Periods
Implementation of AO No. 2024-0016 was previously suspended as follows:
- 60 working days under DC No. 2025-0240
- Additional 60 working days under DC No. 2025-0382
New Extension Granted
Under DC No. 2025-0574, the suspension is now further extended by 120 working days, which will take effect immediately after the lapse of the previous suspension period.
This additional extension aims to:
- Provide sufficient time for FDA’s internal review and operational alignment
- Support equitable application of revised fees
- Prepare stakeholders for the eventual transition to the updated schedule
Continuation of Previous Provisions
All provisions under earlier circulars, DC No. 2025-0240 and DC No. 2025-0382, remain in full force and effect until an official notice lifting the suspension is issued.
Implications to Clients
- The existing FDA fee schedule remains in effect during the suspension period.
- The suspension is temporary; revised or higher fees under AO No. 2024-0016 may still be implemented once the FDA finalizes its review.
- Stakeholders are encouraged to monitor DOH and FDA updates closely, as a subsequent issuance will formally announce the resumption of AO No. 2024-0016 implementation.
- Early anticipation and planning are advisable to prepare for potential fee adjustments once the suspension is lifted.
Effective Date
The Department Circular takes effect immediately.
For inquiries or support regarding medical device regulatory requirements in the Philippines, please contact sales@andamanmed.com.
