Japan's Health Authority (PMDA)
In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW). These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.
|Document Title||Issued by||Description||Available Languages||Download|
|PMDA: Regulations for Buildings and Facilities of Pharmacies||PMDA||Ministerial Ordinance on Standards on the building regulations for Manufacturers Of Cosmetics, Drugs, Medical Devices, and Quasi-drugs as well as pharmacies and distributors of these regulated products.||English||For Sale|
|PMDA: Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products||PMDA||The PMDA provides details for remote-inspections known as compliance inspections.||English||For Sale|