Philippines FDA is rationalizing and streamlining its fee structure to help strengthen regulatory enforcement and post-marketing surveillance activities. The effort will include fee increases that are intended to address rising operational costs.
The new fee structure comes as the Department of Health is in the midst of enacting Administrative Order No. 2018-2002, an updated regulatory system that could be implemented in the second or third quarter of 2018. (Also see "Asia Reg Roundup: Philippines Sets Short Reg System Deadline, Vietnam Defers, Malaysia Extends" - Medtech Insight, 16 Feb, 2018.)
The current schedule of fees was implemented in 2001, and the local FDA has not introduced any increase in fees and charges since then. Now, with upgrades in services and the use of electronic registration, a fee increase is necessary to finance the full implementation of the agency’s Five-Year Development Plan, which was launched in 2016 under Director General Nela Charade Puno. The new fees are being implemented by the FDA Center for Device Regulation, Radiation Health and Research.
Under the new system, a standard medical device manufacturer will have to pay a one-time establishment license fee of 75,000 Philippine Pesos (PhP; US$1,400), plus an annual fee. (See Table 1.)
In addition, device-makers will need to pay "application" and "evaluation" fees for product submissions, in addition to an annual fee for products. (See Table 2.) Other fees will be collected for a quality system certificate (PhP 5,000), safety evaluation report (PhP 5,000), and a certificate of radiation measurement for extremely low frequency (ELF) and radiofrequency radiation (RFR) facilities (PhP 14,000).
* Includes devices incorporating medicinal/therapeutic products
The fees and charges for licensing, inspections and certain laboratory service fees will take effect 15 days after publication in two newspapers of general circulation. Fees and charges for product notification and registration will be formally announced separately.
The agency's five-year plan, in its first phase, seeks to improve information system management, move toward digitization and, generally, improve ways of doing business. A second phase will focus on accelerating growth, investing in new technologies, streamlining application processes and overseeing the launch of electronic licenses to operate (e-LTOs). The LTO validity has been extended from three to five years.
Even before the fee increase, progress has been good, FDA says. Achievements so far include the fulfillment of a 72-hour turnaround time for application processing, cutting the application backlog by 91% and strengthening regulatory enforcement. A joint FDA-Philippine National Police task force has been set up to destroy products that are unfit for use in patients.
On the digital front, online payment systems will be expanded, and an FDA mobile app is being developed for online transactions and payments. Philippines FDA is currently migrating its servers and applications to the cloud.
The additional fees will be used by all supporting units of the FDA, according to the device center. The agency says the funds are needed for it to carry out its mandate of regulatory enforcement, improve its in-house lab services and increase manpower.