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.