The Filipino FDA held a public consultation on December 3, 2009 for its revised fee schedule. The increased fees are primarily to facilitate the recently approved regulations: the Food and Drugs Administration Act of 2009 and the Universally Accessible Cheaper and Quality medicines Act of 2008. The FDA is also planning to increase staff, upgrade and procure lab equipment, and enhance the FDA’s physical and human infrastructure to ensure it can carry out its regulatory responsibilities. Therefore, the FDA needs to increase its income by at least 40 percent to facilitate these improvements. Currently, 50 percent of the FDA’s income comes from registration fees.
Accordingly, the biggest fee increases are for product registration. A new drug’s initial registration used to be 6,667 Philippine Pesos (approximately $144), but is now 210,000 PHP ($4,544). Though initial registration used to be for 1 year, the FDA has extended it for three years. However, the renewal fee has increased from 20,000 PHP ($432) to 70,000 PHP ($1,515) and only lasts for 1 year.
For medical devices, an initial registration used to be 1,500 PHP ($32) and will now be 64,500 PHP ($1,396). Renewal registrations have also increased from 5,000 PHP ($108) to 21,500 PHP ($466). The expiration times have also changed where an initial registration expires in 3 years but a renewal registration expires in one year.
The new schedule also applies to all medical devices, drugs, cosmetics, and food establishments. Importers, exporters, and wholesalers of drugs and medical devices will have increased establishment licensing fees. Initial registration for drug distributors increased from 5,000 PHP (approximately $100) to 17,500 PHP ($756). Renewal fees increased from 10,000 PHP ($216) to 35,000 PHP ($756). For medical device distributors, the initial registration fee increased from 4,000 PHP ($86) to 14,000 PHP ($302). Renewal registration increased from 8,000 PHP ($162) to 28,000 PHP ($604).
Drug manufacturers will also have to pay almost triple in establishment licensing fees compared to the past. For enterprises of 20 million PHP and below (approximately $432,000), initial registration has increased from 10,000 PHP ($217) to 37,000 PHP ($802). Companies between 20 million and 50 million PHP ($1.08 million) will have to pay an initial registration fee of 54,000 PHP (approximately $1,170) instead of 15,000 PHP. Renewal fees have also jumped considerably from 20~30,000 PHP ($433 to $655) to 74~108,000 PHP ($1,600 to $2,337).
Medical device manufacturers also face similar fee hikes with initial registrations ranging from 5~15,000 PHP ($108~$324) to 19~54,000 PHP ($411~$1,168). Renewal fees went from 10~20,000 PHP ($216~$432) to 38~108,000 PHP($822 to $2,337).
The administrative order will take effect fifteen days after its publication in two leading newspapers of general circulation.