Pursuant to FDA Circular No. 2021-020 entitled “Revised Post-Marketing Surveillance Requirements for New Drugs under Monitored Release” dated 21 September, applicant for a Certificate of Product Registration (CPR) of New Drug under Monitored Release shall pay the required fee presented in the table following Administrative Order No. 50 s. 2001 + Legal Research Fund (LRF).
New applications shall pay for a five-year validity while the pending applications that will avail the provision of this Circular and have paid for three-year validity shall settle an additional fee to be granted with five-year validity.
The fees were computed based on the PhP 20,000.00 / 3 years for New Drugs / Monitored release as stated in the said A.O. There would be no change in rates. The increase in fees is the prorated amount commensurate to the extension of validity of the CPR.
|Type of Application
PhP 33,333.33 + LRF
(paid for 3-years and will avail 5-year validity)
PhP 13,333.33 + LRF
New rates shall be published accordingly upon completion of ongoing review on the schedule of fees.
For information and guidance of all concerned.