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International Arrangements
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Confidential Agreements
IMB/JAPAN
Confidentiality Arrangement between the Irish Agency for human medicines, medical devices and veterinary medicines (Irish Medical Board (IMB)) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
Swissmedic/JAPAN
Confidentiality Arrangement between the Swiss Agency for Therapeutic Products (Swissmedic) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
MHRA/JAPAN
Memorandum on Information Exchange between the Medicines and Healthcare products Regulatory Agency and the Ministry of Health, Labour and Welfare (MHLW) Together with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
HSA/JAPAN
Memorandum on Information Exchange between the Health Sciences Authority of the Republic of Singapore and the Ministry of Health, Labour and Welfare (MHLW) Together with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
EC/JAPAN
Confidentiality Arrangement between the European Commission (EC) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
Health Canada/JAPAN
Confidentiality Arrangement between the Health Canada and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
EU/JAPAN
Confidentiality Arrangement between the European Commission (EC) and the European Medicines Agency (EMEA) and the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
USFDA/JAPAN
Confidentiality Commitment Statement of Legal Authority and Commitment from the Pharmaceuticals and Medical Devices Agency (PMDA), Not to Publicly Disclose Non-Public Information Shared by the U.S. Food and Drug Administration, Department of Health and Human Services, Government of the United States of America (USFDA)
Cooperative Agreements
SFDA / JAPAN
Memorandum of Understanding between the Ministry of Health, Labour and Welfare of Japan and the State Food and Drug Administration of the People’s Republic of China regarding Framework for Dialogue and Cooperation (Japanese/Chinese)
* An English translation of the MOU is available
here.