PMDA (Japan)
Pharmaceuticals and Medical Devices Agency
Japan's regulatory agency for pharmaceuticals, medical devices, regenerative medicines and cosmetics — operating under the PMD Act.
PMDA, in partnership with the Ministry of Health, Labour and Welfare (MHLW), administers Japan's Pharmaceuticals and Medical Devices Act (the PMD Act, formerly PAL). It conducts marketing-authorisation reviews, GMP/QMS conformity assessments, post-market safety monitoring and consultation services. Japan participates in MDSAP and accepts ICH guidelines, but the PMD Act includes Japan-specific requirements (Marketing Authorisation Holder system, J-GMP Ordinance 179).
For pharma the J-GMP ministerial ordinance and PIC/S GMP guide both apply; for devices Japan's QMS Ordinance 169 mirrors ISO 13485 with local additions.
- Japan PMD Act
- MHLW Ordinance 179 (J-GMP)
- MHLW Ordinance 169 (J-QMS)
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