The Food and Drug Administration (FDA) of the Philippines has implemented new guidelines that adjust fees for facility registration and Certificate of Product Registration (CPR) while extending the validity period for health products. The new fees are calculated annually and multiplied by the number of allowable years of validity.
The Food and Drug Administration ( FDA ) has implemented new guidelines adjusting fees while extending the validity of the Certificate of Product Registration ( CPR ) for health products . Under Administrative Order 2024-0016, fees for facility registration and CPR are now calculated annually and multiplied by the number of allowable years of validity.
For instance, a high-risk food product with a three-year CPR validity will incur an annual application fee of P3,500, amounting to P10,500 over three years, plus a P105 legal research fee (LRF). \The FDA has also set the following fees for various applications: P500 for pre-assessment, P160 for a permit to carry or mail, P100 per page for authentication, P1,650 for a Certificate of Free Sale, P5,000 for reconsideration requests, and P500 for other certifications or requests. Other charges include: P500 for re-issuance of an authorization or license P250 to P1,000 for discount scheme promotions P250 to P5,000 for non-discount scheme promotions. These fees are subject to an additional charge of either P10 or 1% of the application fee, whichever is higher. \The CPR validity has also been updated: Food products: Initial validity of 3 or 6 years, renewable for 12 years. Devices: 6 years, renewable for 12 years. Drugs: 6 years, renewable for 12 years. Household/urban pesticides and hazardous substances: 6 or 12 years, renewable for 12 years. The FDA stated that the fee adjustments are necessary to align with technological advancements and the growth of the health product industry. The Administrative Order noted, “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 to be able to meet and sustain the increasing demands of providing the FDA stakeholders quality and efficient services.” — DVM, GMA Integrated New
HEALTH PRODUCTS FDA FEES CPR VALIDITY
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