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mentioned, in the NDA, all the data must be presented in Japanese, accompanied by a copy in the original language. |
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The Japanese regulations covering the clinical program correctly stress its importance in evaluating the test medication, the need to ensure the use of appropriately experienced physicians at adequately equipped hospitals, and the need to ensure adherence to procedures, such as the Declaration of Helsinki, to ensure patient protection. Although these are consistent with most other parts of the world, there are differences in the conduct of clinical trials in Japan, both in organizational and philosophical terms. The industry sponsor enters into a contractual agreement with a medical institution in which the study is to be conducted and the investigator in charge of the study is directly responsible for the clinical trial. When several investigators in several institutions are involved, a supervisory investigator is appointed with responsibility for the oversight of the entire trial. The supervisory investigator need not be affiliated with any of the participating institutions. Unlike the Western hemisphere, this supervisory investigator is legally responsible for the part of the development program that he supervises. He is responsible for ensuring the ethical and scientific validity of the study and is authorised to finalize and amend the protocol and to request additional information, such as additional preclinical data. All scientific and study-related communications with the sponsor are channeled through the supervisory investigator, who also is responsible for inspection of completed clinical report forms and the preparation of the study report. |
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For each clinical study of an NCE, a clinical trial notification (CTN) must be submitted to the Koseisho. This document contains information about the |
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previous clinical study results; |
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control and manufacturing data; and |
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The CTN must be submitted to the Koseisho no later than 4 weeks before the commencement of the study. Although it is their right, it is unusual for the Koseisho to comment. As in other countries, the duration of clinical trials with NCEs depends on the preclinical toxicity data. These durations are listed in Table 3, and additional requirements have been discussed under preclinical needs. |
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Japanese clinical development programs may involve smaller patient numbers than Western programs, although this is becoming less common. Japan presently is flexible in its requirements. For a chronic-use adult therapy, the |
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