Law No. 145 on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. Pays/Territoire Japon Type du document Législation Date 1960 (2015) Source FAO, FAOLEX Sujet Bétail, Alimentation et nutrition, Plantes cultivées Mot clé Pesticides Enregistrement Résidus Toxicité/empoisonnement Infractions/sanctions Santé publique Commerce intérieur Commerce international Contrôle de qualité alimentaire/innocuité des produits alimentaires Développement agricole Médicaments Santé des animaux Agents de lutte biologique Pollution du sol/qualité Aire géographique Asie, Asie et Pacifique, Asie Orientale, Pacifique Nord, Pacifique Nord Occidental 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. Résumé 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. Texte intégral Anglais Site web www.japaneselawtranslation.go.jp Références - Législation Implementé par Enforcement Order of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Cabinet Order No. 11). Législation | Japon | 1961 Mot clé: Mise en application, Pesticides, Enregistrement, Résidus, Toxicité/empoisonnement, Infractions/sanctions, Santé publique, Commerce intérieur, Commerce international, Contrôle de qualité alimentaire/innocuité des produits alimentaires, Développement agricole, Médicaments, Santé des animaux, Agents de lutte biologique, Pollution du sol/qualité Source: FAO, FAOLEX Regulatory Rules for Veterinary Medicinal Products, Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107, 2004. Législation | Japon | 2004 (2017) Mot clé: Médicaments, Maladie des poissons, Gestion et conservation des pêches, Enregistrement, Renforcement des capacités, Certification, Commerce intérieur, Commerce international, Santé des animaux, Parasites/maladies Source: FAO, FAOLEX Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products No. 74, 1997. Législation | Japon | 1997 (2014) Mot clé: Normes, Recherche, Monitorage, Médicaments, Maladie des poissons, Santé des animaux, Parasites/maladies Source: FAO, FAOLEX Ministerial Ordinance on Standards for Post-Marketing Surveillance and Testing of Veterinary Medical Products No. 33, 2005. Législation | Japon | 2005 (2016) Mot clé: Inspection, Monitorage, Médicaments, Maladie des poissons, Gestion et conservation des pêches, Commerce intérieur, Commerce international, Santé des animaux, Parasites/maladies Source: FAO, FAOLEX