SUBJECT: New Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration, and Other Authorizations and Regulatory Services
I. BACKGROUND AND RATIONALE
Enshrined in Section 12, Article XIII of the 1987 Philippine Constitution, it is the responsibility of the State to establish and maintain an effective food and drug regulatory system. A system that is responsive to the country's current health needs as and capable of providing innovative solutions to unfamiliar problems. Consistent with this national policy, the Congress of the Philippines passed three landmark legislations, namely: Republic Act (RA) No. 9502, (Universally Accessible Cheaper and Quality Medicine Act of 2008), R.A. No. 9711, (Food and Drug Administration Act of 2009) and R.A. No. 10611 (Food Safety Act of 2013), for the promotion and protection of public health and welfare.
Section 31 of R.A. No. 9502 and Section 18 of RA No. 9711, authorize the Food and Drug Administration (FDA) to retain all fees, fines, royalties and other charges under a Special Regulatory Fund. These fees, fines and other charges are dedicated for the following purposes: (a) operations, which includes upgrading of its facilities, equipment outlay, human resource development and expansion; (b) acquisition of the appropriate office space, as well as purchase of laboratory equipment and motor vehicles; (c) upgrading of its current facilities, equipment and maintenance of these facilities; (d) funding for operating expenses of the central office laboratory divisions and satellite laboratories; (e) post market surveillance and other activities or services of the FDA in the performance of its mandate. Furthermore, R.A. No. 9711 supports the self-sufficiency and fiscal sustainability of the FDA.
FDA is rationalizing and streamlining its fee structure to make adjustments in order to: strengthen regulatory enforcement and post-marketing surveillance activities and address rising operational costs. The agency bears costs relating to processing of applications as well as expenses spent for the following: (1) development of qualified personnel with highly specialized skills in the evaluation of health products; (2) improvement and maintenance of electronic systems; (3) upgrade of facilities; (4) development of smart regulation mechanisms; and (5) initiatives to foster public information and services.
The existing schedule of fees was implemented as far back as the year 2001. The FDA has not introduced any increase in fees and charges since. With its upgrade in services and adopting the use of electronic registration, the modification in its current fees and charges is one way of assuring the full implementation of the Agency’s Five Year Development plan, sustaining its services and operations, and supporting its continued improvement and growth.
In the interest of service and pursuant to the DOF-DBM-NEDA Joint Circular No. 1-2013, also known as the “ Implementing Rules and Regulations of Administrative Order No. 31 s. 2012 on the Rationalization of Rates of Fees and Charges, Increase in Existing Rates and Imposition of New Fees and Charges”, the heads of bureaus, offices or agencies, upon approval of the concerned department heads are authorized to revise their rates of fees and charges pursuant to Section 54 (1), Chapter 12, Book IV of the Executive Order No. 292 or the Administrative Code of 1987.
As such, FDA is restructuring its fees and charges at a level commensurate with the cost of regulating health products to be able to improve agency performance, sustain its operations, and achieve its legal mandate.