Manila City, Philippines—The Food and Drug Administration (FDA) of the Philippines is implementing significant adjustments to its schedule of fees and charges for licenses, permits, and product registrations, set to take effect on January 12, 2025. This comprehensive update, detailed in Administrative Order (AO) No. 2024-0016 and published on December 28, 2024, marks the first major revision to the agency's fee structure in over two decades.
The FDA asserts that the fee increases are vital to "meet and sustain the increasing demands of providing the FDA stakeholders quality and efficient services" and to strengthen regulatory enforcement, particularly in post-marketing surveillance activities. This move aims to bolster the agency's operational capacity, including funding facility upgrades and enhancing staff remuneration for assessors.
Under the new order, the cost of obtaining a Certificate of Product Registration (CPR) for various health products, including food, drugs, cosmetics, and medical devices, will see notable increases. For example, specific fees for facility registration and product certification will now be calculated annually and multiplied by the number of allowable years of validity. However, in a bid to streamline processes, the FDA is also introducing extended validity periods for certain authorizations; food products could see renewals for up to 12 years, while drugs and devices may also achieve similar longer terms.
"With the current innovations in technology and the improvement of the country's economy as evidenced by the flourishing health product industry, a commensurate increase in the fees and charges is considerably needed," an excerpt from the Administrative Order noted, emphasizing the agency's need for updated resources to efficiently regulate a rapidly expanding sector.
Initial reactions from affected industries have varied, with some businesses expressing concerns over the immediate impact on their operational expenses, especially those with extensive product portfolios. The FDA has, however, signaled flexibility by temporarily suspending pre-assessment fees for certain applications during the full implementation phase of AO No. 2024-0016. Businesses are strongly advised to thoroughly review the complete Administrative Order and its annexes, which detail the specific fees for various application types, including surcharges for late renewals.
