Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. País/Territorio Japón Tipo de documento Legislación Fecha 1960 (2015) Fuente FAO, FAOLEX Materia Ganado, Alimentación y nutrición, Cultivos Palabra clave Plaguicidas Registro Residuos Toxicidad/envenenamiento Infracciones/sanciones Salud pública Comercio interior Comercio internacional Control de calidad de los alimentos/inocuidad de los alimentos Desarrollo agrícola Medicamentos Sanidad animal Agentes de control biológico Contaminación del suelo/calidad Área geográphica Asia, Asia y Pacifico, Asia Oriental, Pacífico Norte, Pacífico Nordoeste 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. Resumen 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. Texto completo Inglés Página web www.japaneselawtranslation.go.jp Referencias - Legislación Implementado por Enforcement Order of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11). Legislación | Japón | 1961 Palabra clave: Cumplimiento/aplicación, Plaguicidas, Registro, Residuos, Toxicidad/envenenamiento, Infracciones/sanciones, Salud pública, Comercio interior, Comercio internacional, Control de calidad de los alimentos/inocuidad de los alimentos, Desarrollo agrícola, Medicamentos, Sanidad animal, Agentes de control biológico, Contaminación del suelo/calidad Fuente: FAO, FAOLEX Regulatory Rules for Veterinary Medicinal Products, Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107, 2004. Legislación | Japón | 2004 (2017) Palabra clave: Medicamentos, Enfermedades de los peces, Manejo y conservación pesquera, Registro, Fortalecimiento de la capacidad, Certificación, Comercio interior, Comercio internacional, Sanidad animal, Plagas/enfermedades Fuente: FAO, FAOLEX Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products No. 74, 1997. Legislación | Japón | 1997 (2014) Palabra clave: Normas, Investigación, Monitoreo, Medicamentos, Enfermedades de los peces, Sanidad animal, Plagas/enfermedades Fuente: FAO, FAOLEX Ministerial Ordinance on Standards for Post-Marketing Surveillance and Testing of Veterinary Medical Products No. 33, 2005. Legislación | Japón | 2005 (2016) Palabra clave: Inspección, Monitoreo, Medicamentos, Enfermedades de los peces, Manejo y conservación pesquera, Comercio interior, Comercio internacional, Sanidad animal, Plagas/enfermedades Fuente: FAO, FAOLEX