PMDA

Also known as: Pharmaceuticals and Medical Devices Agency

Japan's medicines regulator.

Definition

The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's independent regulator for medicines, medical devices, and regenerative-medicine products. PMDA review timelines run ~12 months for new drugs. Review reports are published in English and Japanese.

See also

• ICH — The global body that harmonises drug regulation across the US, EU, Japan, and other markets.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval