Filipinos can look forward to cheaper and just as effective medicines after President Marcos directed the Food and Drug Administration to streamline the approval of drug application processes from 120 days to 45 days.
“[This will] provide further cheaper medicine accessibility for all the Filipinos,” FDA director-general Samuel Zacate said after a recent sectoral meeting at the Palace.
He said the President also ordered health officials to study the establishment of “pharma-zones” in Philippine Economic Zone Authority-controlled areas to test and register medicines directly.
“The FDA will play a role in ensuring that when a medicine enters, it goes straight to testing and registration to make sure it gets quick and wide coverage, especially for essential medicines,” Zacate said.
Filipinos spent nearly P10,000 a year on health-related goods and services in 2021 on average, making healthcare one of the biggest family expenditures.
“We stand behind the promotion of generic medicines. They provide accessible and cost-effective alternatives without compromising quality. This initiative aligns with our mission to ensure affordable healthcare for all Filipinos,” Dr. Caluya III of the Department of Health’s Pharmaceutical Division said in an earlier interview.
He said the FDA will use the Facilitated Review Pathway as an alternative registration procedure, which would refer to drug regulatory agencies overseas in making its assessment to ensure their efficiency.
Zacate said this way, the number of requirements will remain unchanged despite the shortened period.
“We do not reduce the number of requirements, but we use reliance, example is that, if it came from, say the US FDA,” Zacate said.
Zacate said the FDA is also seeking to lengthen the validity of the license to operate and certificate of product registration from the current five-year renewal period to 10 years.
He likewise emphasized the need to fully digitize the FDA.
“We already have talks with the Department of ICT and the Anti-Red Tape Authority to establish a one-stop shop. It will help greatly the stakeholders of the pharmaceutical industry,” Zacate said.