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 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.
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: 67176cfef425e3f3d598f8d6216dfd2b4687049e3c204da47ef07cb1a8671542
Primary Citations — 5 traced to source
- {"title":"Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960, as amended 2014, 2019, 2020)","url":"https://laws.e-gov.go.jp/law/335AC0000000145","section":"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)","relevance":"Primary Japanese pharmaceutical and medical device legislation; requires MHLW or PMDA marketing approval before sale in Japan, GMP compliance, post-marketing surveillance with ADR reporting within 15 days for serious unexpected reactions, and mandatory recall cooperation; 2014 amendments created the PMD Act from the former Pharmaceutical Affairs Act"}
- {"title":"MHLW Ordinance on Manufacturing Control and Quality Control for Drugs (MHLW Ordinance No. 179 of 2004) - Japan GMP Regulations","url":"https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/150407-01.pdf","section":"Chapters 1-9 (quality management systems, batch release, deviations, change control, validation, document control, GMP inspections)","relevance":"Japanese GMP ordinance specifying manufacturing control and quality control requirements for drug manufacturing facilities; applies to both domestic and overseas manufacturing facilities supplying the Japanese market; PMDA conducts GMP inspections against this ordinance as part of drug and medical device approval reviews"}
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