What Japan Pharmaceutical and Medical Devices Act 2014 requires
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, substantially amended in 2014 as the Pharmaceutical and Medical Devices Act and further amended in 2019 and…
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Pillar: Pharmaceuticals & Life Sciences · Authority: National Diet of Japan · Version: 1.0.0 · Last updated:
Primary source: https://laws.e-gov.go.jp/law/335AC0000000145
SHA-256 integrity: 769cc5452623235f35791310b8935c4d54787a88522da45047565d85e4eccfef
Primary Citations — 5 traced to source
- Articles 2 (product classification), 13-14 (manufacturing and marketing approval), 14-3 (GMP), 23-2-2 (medical device classification), 23-25 (regenerative medicine products), 68-2 (labelling), 68-10 (adverse reaction reporting), 72-4 (recall orders), 74 (penalties) — Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, as amended 2014, 2019, 2020)
- Chapters 1-9 (quality management systems, batch release, deviations, change control, validation, document control, GMP inspections) — MHLW Ordinance on Manufacturing Control and Quality Control for Drugs (MHLW Ordinance No. 179 of 2004) - Japan GMP Regulations
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/jp-pharmaceutical-medical-devices-act-2014.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/jp-pharmaceutical-medical-devices-act-2014.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/jp-pharmaceutical-medical-devices-act-2014
- Back to registry: Browse all 10,102 compliance nodes