Philippine Department of Health Extends Suspension of New FDA Fee Schedule

On 5 September 2025, the Philippine Department of Health (DOH) extended the suspension of Administrative Order (AO) No. 2024-0016, which introduces a new schedule of fees and charges of the Philippine Food and Drug Administration (FDA).

Department Circular No. 2025-0382, effective immediately, extends the suspension under Department Circular No. 2025-0240 by 60 working days. All provisions of the previous circular remain in effect during this period.

The extension allows businesses to continue operating under the current fee structure while preparing for upcoming changes. For overseas manufacturers and distributors, it provides additional time to refine regulatory strategies and budget planning before the new fees take effect.

New Philippine FDA Fee Extension Explained

Understanding the recent suspension requires looking at both the substance of the new FDA fee schedule and the reasons behind the delay in its implementation.

Background on the New Schedule of Fees

Administrative Order No. 2024-0016 “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration” replaces the long-standing AO No. 50 s. 2001, modernising the FDA’s fee structure to reflect technological and economic developments in the health products sector.

The revised fees are designed to better reflect the actual cost of regulatory activities and sustain the agency’s ability to deliver quality services while strengthening public health protections.

Scope of Application for the New Philippine FDA Fees

The new schedule applies to all establishments, facilities, and health products under FDA jurisdiction, including public and private entities, national and local government agencies, and educational institutions.

Some categories remain under separate regulations, including:

Salt manufacturers, distributors, importers, and traders: regulated under RA No. 8172 (ASIN Law), its revised Implementing Rules and Regulations (IRR), and future amendments
Foreign drug manufacturers with Certificates of GMP Compliance: governed by AO No. 2013-0022 and FDA Circular (FC) No. 2014-016
Accreditation fees for local and foreign bioequivalence testing centers: governed by AO No. 2012-0024 and its amendments
Local GMP certification fees for drug manufacturers: remain under Section D Item 2.2 of AO No. 50 s. 1989 until new regulations with corresponding fees are issued
Fees for pest control operators, pesticide handlers, and training providers: governed by AO No. 2019-0010 and its amendments

Activities Covered by the New Philippine FDA Fees

The application fees for authorisation or accreditation under the new schedule cover a broad range of regulatory activities, including:

Receiving and processing of application documents
Pre-marketing activities, including assessment, technical evaluation, and pre-licensing inspections
Post-marketing surveillance, including sample collection, laboratory testing, complaints handling, safety monitoring, inspections, vigilance, post-evaluation, product verification, and advertisement monitoring
Printing, records management, archiving, and administrative support

Reasons for the Suspension and Extension

While the policy objective behind the fee revisions is clear, the timeline for implementation has been adjusted to give stakeholders more time to adapt.

Key developments include:

10 June 2025 – Department Circular No. 2025-0240 suspends AO No. 2024-0016 for 60 working days to allow consultations and review of the proposed fee schedule.
Mid–2025 – During consultations, additional issues and recommendations emerge, requiring further consideration by the FDA and DOH.
5 September 2025 – Department Circular No. 2025-0382 extends the suspension for another 60 working days, effective immediately after the first suspension ends.

Together, these extensions reflect the authorities’ decision to prioritise thorough consultation and refinement before implementing the new fee structure.

Next Steps for Companies

The new Philippine FDA fee suspension period offers a valuable window to prepare for the eventual implementation of AO No. 2024-0016.

During this period, key priorities should include:

Advancing submissions where possible to take advantage of the current fees
Adjusting budgets and forecasts to reflect the upcoming fee changes
Tracking DOH and FDA updates closely for any shifts to the implementation timeline
Coordinating with local regulatory partners to keep submission plans on track once the new structure is in place

As companies review their plans for the Philippines, it is also a good moment to assess broader regulatory needs across Southeast Asia. A coordinated approach can streamline market access and ensure readiness for upcoming regulatory changes.

Cisema supports this through strategic planning, feasibility assessments, and tailored regulatory roadmaps for medical device and IVD manufacturers navigating evolving requirements in the Philippines and the region.

To make the most of this transition period or to plan your next steps across Southeast Asia effectively, get in touch with our team.