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FDA, Japan’s PMDA Strengthen Ties To Accelerate Regulation Processes

The collaboration between FDA and PMDA signals a vital step towards improving patient access to essential health products.

FDA, Japan’s PMDA Strengthen Ties To Accelerate Regulation Processes

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The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential medicines and medical devices.

In a news release on Wednesday, the FDA said the meeting also discussed other key topics, such as international regulatory collaboration, pharmacovigilance in Asia, and the agency’s relationship with clinical trial sites.

Policy and Planning Service – International Affairs Unit Senior Health Program Officer Ray Mark Morante headed the session. Other key attendees from the Philippines included representatives of the Office of the Director General, Center for Drug Regulation and Research, and Field Regulatory Operations Office.

PMDA Asia Office head Kitahara Jun and First Secretary of the Embassy of Japan in the Philippines Aoki Fumiko, meanwhile, led the Japanese contingent.

The discussions also covered upcoming PMDA-ASEAN meetings, international regulatory frameworks like the International Medical Device Regulators Forum, and plans for the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) training in 2025.

“Both agencies reaffirmed their commitment to improving drug and device evaluation processes and aligning these with global best practices,” the FDA said.

“Future collaborations are expected to strengthen regulatory efficiency and expand international partnerships, ensuring better healthcare access for the general public in both countries.” (PNA)