Pharmaceuticals and Medical Devices Agency
Japanese regulator and ICH founding member; administers GMP under the PMD Act.
WHAT PMDA COVERS
The Pharmaceuticals and Medical Devices Agency performs scientific review, GMP inspection, and safety monitoring for Japan, working alongside the Ministry of Health, Labour and Welfare, which holds the formal approval authority. The governing law is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act).
WHERE IT SITS INTERNATIONALLY
Japan is a founding regulatory member of ICH, and PMDA is a PIC/S participating authority — so its GMP expectations align closely with the PIC/S guide while retaining Japan-specific requirements.
HOW ITS REQUIREMENTS BITE
PMDA conducts GMP compliance inspections tied to product approval and to periodic renewal, for domestic and foreign manufacturers supplying Japan. Japan operates a marketing authorisation holder system in which the domestic MAH carries defined quality and safety responsibilities, so a foreign manufacturer’s compliance is mediated through that relationship.
WHAT PMDA PUBLISHES
- 01Japanese Pharmacopoeia (JP)
- 02MHLW ministerial ordinances and PMDA notifications interpreting the PMD Act
- 03GMP inspection guidance and Japan-specific requirements
- 04Review reports and safety information for approved products
- 05ICH-aligned guidelines as adopted into the Japanese framework
WHAT PRACTITIONERS GET WRONG
- ›The MAH system means a domestic entity holds defined quality and pharmacovigilance obligations on your behalf.
- ›Japanese Pharmacopoeia requirements can differ in detail from USP or Ph. Eur. — check the monograph, do not assume equivalence.
- ›Documentation and inspection are commonly conducted in Japanese; translation quality is a real project risk.
- ›PMDA does the review and inspection; MHLW grants the approval.
PMDA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN PMDA’S REMIT
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