The Food and Drug Administration (FDA) Administrative Order No. 2024-0016 Entitled “Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration” took effect on 12 January 2025.
In one of its stakeholder engagements, the FDA highlighted that the new guidelines aim to strengthen regulatory enforcement and post-marketing surveillance activities, as well as address the agency’s rising operational costs.
Relatively, the revised fees are intended to cover costs relating to processing of applications
and funding key initiatives, including:
Development of qualified personnel with highly specialized skills in health products evaluation;
Improvement and maintenance of electronic systems;
Upgrade and maintain facilities;
Development of smart regulation mechanisms; and
Advancement of public information and service initiatives.
The FDA explained that the adjustments to its current fees and charges supports the full implementation of the Agency’s Five Year Development plan, sustaining its services and operations, and supporting its continued improvement and growth.
Additionally, the FDA stated that the computation of new fees was guided by the National Tax Research Center (NTRC) under the Department of Finance. The calculations were based strictly on the actual costs of processing applications, without additional or arbitrary charges.
Furthermore, fees and charges for the following are not covered by this Order:
1. Authorizations for Pest Control Operators and Applicators (PCOs/PCAs);
2. Authorizations for Household/Urban Hazardous Substances (HUHS) establishments and
products; and,
3. Laboratory services (except, suitability evaluation of food contact materials, evaluation of test results from accredited laboratories, lot release certification, and batch notification certificates)
Further details of the said AO can be found through this link and for the complete schedule of detailed fees and charges, you may visit this link. PKC