In a pivotal meeting held in Alabang, Muntinlupa, the Philippine Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have solidified their partnership to accelerate the approval process for essential medicines and medical devices. The meeting, which took place on February 18, 2025, saw both agencies recommit to enhancing their evaluation processes and aligning them with international standards.
The FDA announced on February 19, 2025, that the discussions focused on optimizing the facilitated review pathway (FRP) to ensure quicker access to critical healthcare products. The agenda also included international regulatory collaboration, pharmacovigilance in Asia, and strengthening ties with clinical trial sites.
Leading the Philippine delegation was Ray Mark Morante, Senior Health Program Officer from the Policy and Planning Service – International Affairs Unit. The team also comprised representatives from the Office of the Director General, Center for Drug Regulation and Research, and Field Regulatory Operations Office.
From Japan, the delegation was headed by Kitahara Jun, head of the PMDA Asia Office, and Aoki Fumiko, First Secretary of the Embassy of Japan in the Philippines. The talks extended to future PMDA-ASEAN meetings, international regulatory frameworks such as the International Medical Device Regulators Forum, and the upcoming training sessions at the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) in 2025.
The FDA emphasized that both agencies are dedicated to improving their drug and device evaluation processes to meet global best practices. This collaboration is expected to enhance regulatory efficiency and broaden international partnerships, ultimately improving healthcare access for citizens of both nations.