{
  "node_id": "jp-pharmaceutical-medical-devices-act-2014",
  "title": "Japan Pharmaceutical and Medical Devices Act 2014",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2020-09-01",
  "bluf": "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 2020), requires manufacturers and marketing authorization holders to obtain individual product approval from the Ministry of Health, Labour and Welfare or the Pharmaceuticals and Medical Devices Agency before placing drugs, medical devices, regenerative medicine products, quasi-drugs, or cosmetics on the Japanese market under Article 14, classifies medical devices into four classes (Class I exempt from approval through Class III requiring full review) under Article 23-2-2, imposes Good Manufacturing Practice obligations on manufacturing facilities under Article 14-3, requires post-marketing surveillance and safety reporting of adverse drug reactions to PMDA within 15 days for serious unexpected reactions under Article 68-10, and imposes penalties up to 3 years imprisonment and JPY 3 million fines for marketing unapproved products.",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "jp-appi-2022",
      "ca-food-drugs-act-1985",
      "eu-medical-devices-regulation-mdr-2017-745-implementation"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "jp-appi-2022",
    "ca-food-drugs-act-1985",
    "eu-medical-devices-regulation-mdr-2017-745-implementation"
  ],
  "primary_citations_count": 5
}