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
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