PMDA (Pharmaceuticals and Medical Devices Agency)

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s regulatory authority responsible for ensuring the safety, quality, and efficacy of pharmaceuticals, medical devices, and other healthcare products before they are marketed. Operating in close collaboration with the Ministry of Health, Labour and Welfare (MHLW), the PMDA plays a central role in safeguarding public health through scientific evaluation, ongoing surveillance, and regulatory enforcement.

While the MHLW issues product approvals, the PMDA is responsible for conducting the technical and scientific evaluations that support product approvals, as well as post-market safety monitoring. The agency conducts rigorous scientific assessments to confirm that products meet established standards prior to market entry. Its role extends beyond pre-market review, as it also oversees post-market surveillance, monitoring adverse events, recalls, and emerging safety concerns to ensure products remain safe throughout their lifecycle.

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