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| Table 1 The Subcommittees on New Drugs: Division of Therapeutic Responsibility | | First subcommittee | Gastrointestinal
Genitourinary
Hormonal
Topical | | Second subcommittee | Cardiovascular | | Third subcommittee | Central nervous system
Sensory organs
Respiratory
Allergy | | Fourth subcommittee | Antibiotics
Chemotherapeutic agents |
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to GLP, the Lyakuhin Kikou does seek the cooperation of the appropriate Prefectural Office. |
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If one excludes the time taken for the pharmaceutical company to respond to questions, the regulatory process from application to approval for a new drug averages 13.9 months, with the longest time, during the 198092 period, being 21.8 months [9]. Overall, branded generics take less time than new entities, usually less than 12 months. If one compares the United States and the European performance, these times are by no means unfavorable. |
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As in the United States, generally new medicines in Europe are evaluated for marketing approval on the basis of quality, safety, and efficacy. Although the fourth hurdle, cost, often an issue in European approvals, is absent, the Japanese government has, over the past several years, contained pharmaceutical costs by frequently mandating cost reductions of established products. Such practice accords with its policy of holding down the health fund payments to hospitals and health care workers even though both the government and union health funds have enormous reserves. |
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For those contemplating drug registration in Japan, a number of general points are worth contemplating. A significant point of deviation from the requirements of other agencies is that the majority of data contained in a Japanese NDA must be published [10]. This is part of a philosophy of minimizing government responsibility for drug evaluation. They have elected to have neutral third parties do the work. To this end clinical studies must be conducted by independent investigators with a neutral supervisory investigator, as will be seen, and NDAs are evaluated by an assembly of independent advisors, as previously stated. The evaluation of study results by independent journal |
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