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Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices.

Country/Territory
Japan
Document type
Legislation
Date
1960 (2015)
Source
FAO, FAOLEX
Subject
Livestock, Food & nutrition, Cultivated plants
Keyword
Pesticides Registration Residues Toxicity/poisoning Offences/penalties Public health Internal trade International trade Food quality control/food safety Agricultural development Drugs Animal health Biological control agents Soil pollution/quality
Geographical area
Asia, Asia and the Pacific, Eastern Asia, North Pacific, North-West Pacific
Entry into force notes
This Law enters into force from the day specified by Cabinet Order within a period not exceeding six months from the date of promulgation.
Abstract

This Law, consisting of 91 articles divided into seventeen Chapters, establishes Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. It aims to secure the quality, efficacy and safety of pharmaceuticals, quasi-drugs, cosmetics, medical devices, regenerative medicine products (pharmaceuticals), to provide the control required for preventing the occurrence or spread of hazards to public health and hygiene caused by the use of such pharmaceuticals, to take measures against designated substances, and to improve public health and hygiene by taking necessary measures for the promotion of research and development of pharmaceuticals, medical devices and regenerative medicine products which are especially important for medical practice. In order to achieve the purpose of this Law, the national government shall develop and implement measures required to secure the quality, efficacy and safety of pharmaceuticals, to prevent the occurrence or spread of hazards to public health and hygiene caused by the use of these pharmaceuticals, and other necessary measures.

Full text
English
Website
www.japaneselawtranslation.go.jp

References - Legislation

Implemented by

Enforcement Order of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11).

Legislation | Japan | 1961

Keyword: Enforcement/compliance, Pesticides, Registration, Residues, Toxicity/poisoning, Offences/penalties, Public health, Internal trade, International trade, Food quality control/food safety, Agricultural development, Drugs, Animal health, Biological control agents, Soil pollution/quality

Source: FAO, FAOLEX

Regulatory Rules for Veterinary Medicinal Products, Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107, 2004.

Legislation | Japan | 2004 (2017)

Keyword: Drugs, Fish disease, Fishery management and conservation, Registration, Capacity building, Certification, Internal trade, International trade, Animal health, Pests/diseases

Source: FAO, FAOLEX

Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products No. 74, 1997.

Legislation | Japan | 1997 (2014)

Keyword: Standards, Research, Monitoring, Drugs, Fish disease, Animal health, Pests/diseases

Source: FAO, FAOLEX

Ministerial Ordinance on Standards for Post-Marketing Surveillance and Testing of Veterinary Medical Products No. 33, 2005.

Legislation | Japan | 2005 (2016)

Keyword: Inspection, Monitoring, Drugs, Fish disease, Fishery management and conservation, Internal trade, International trade, Animal health, Pests/diseases

Source: FAO, FAOLEX