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  1. Confidentiality Commitments

PMDA Japan - FDA, Confidentiality Commitment

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)

The Food and Drug Administration, Department of Health and Human Services, Government of the United States of America (USFDA) is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to the Pharmaceuticals and Medical Devices Agency (PMDA), which is affiliated with the Ministry of Health Labour and Welfare of Japan in the approval of pharmaceuticals and medical devices, regarding the USFDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

The PMDA working together with MHLW understands that some of the information it receives from the USFDA may include non-public information exempt from public disclosure under the laws and regulations of the Government of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. The PMDA understands that this non-public information is shared in confidence, and that the USFDA considers it critical that the PMDA maintain the confidentiality of the information. Public disclosure of this information by the PMDA could seriously jeopardize any further scientific and regulatory interactions between the USFDA and PMDA. The US FDA will advise the PMDA of the non-public status of the information at the time that the information is shared.

Therefore, PMDA certifies that it:

has the authority to protect the non-public information provided to the PMDA in confidence by the USFDA from public disclosure; will not publicly disclose the USFDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from the USFDA that the information no longer has non-public status; will inform the USFDA within two working days of any effort made to obtain the US FDA-provided non-public information from the PMDA by judicial or legislative mandate. If such judicial or legislative mandate orders disclosure of the USFDA- provided non-public information, the PMDA will take all measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and will promptly inform the USFDA of any changes to laws, policies or procedures that would affect the PMDA’s ability to honor the agreements in this document.

___________/s/_____________
Signature of foreign government official

Akira Miyajima
__________________________________
Print or Type foreign government official

Chief Executive
___________________________________
Title of foreign government agency official

Pharmaceuticals and Medical Devices Agency
______________________________
Name of foreign government agency

Address:
ShinKasumigaseki Bldg, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-0013

Contact Point:
International Affairs and Human Resources Development Division,
Office of Planning and Coordination

Telephone: +81-3-3506-9456
Facsimile: +81-3-3506-9461

Date: July 29, 2004

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