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 organizations both handle a wide range of activities, from approval reviews to post-market surveillance.
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Application for Accreditation of Foreign Manufacturers to PMDA in Japan | PMDA | A foreign manufacturer (a person/a company) intending to manufacture drugs, quasi-drugs, or medical devices in foreign countries and export them to Japan, is required to be accredited by the Minister of Health, Labor, and Welfare as an “Accredited Foreign Manufacturer”, specified in Article 13-3 of PAL, in the same way that a Japanese manufacturer is licensed. | English | For Sale |
| 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 |