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conducted by the first applicant to evaluate further the risk-to-benefit ratio. Without obtaining these data from the original applicant, filing of an NDA would seem to be not possible. Currently this would appear to effectively increase the market exclusivity period for an innovative product to 10 years. However, the definition of what constitutes a me-too product has still to be tested. In line with this change from 6 to 10 years, records of and materials used in all tests included in the registration application must be retained at least till reexamination. Although this can accentuate storage problems, it is a small price for an innovative company to pay for such potential benefits. |
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In Japan, NDAs are submitted to the MHW by way of the pharmaceutical section of the Prefectural Government Office within the business district of the applicant, and if no objections are raised, the NDA is forwarded to the MHW. Responsibility for the regulation of pharmaceutical products is situated within the Pharmaceutical Affairs Bureau (PAB), which is one of nine within the MHW (Figure 1). The PAB provides the necessary framework and administration to facilitate the drug regulatory process by auditing the drug dossiers to ensure that the data are complete and satisfy the Japanese guidelines [8]. On completion of review by the PAB, a meeting takes place to advise the pharmaceutical company of any deficiencies in content or format within the NDA that must be put right before the review can progress. This frequently requires several meetings with submission of supplemental data by the sponsor. Once the PAB declares the NDA acceptable, it is passed to the appropriate subcommittee of the Central Pharmaceutical Affairs Council (CPAC) for detailed scientific and medical review. Some drugs may be examined by more than one subcommittee; a combination product containing a new chemical entity (NCE) will be referred to the subcommittee on combination drugs and to the appropriate subcommittee for new drugs. These subcommittee reviews are conducted by highly experienced members of the Japanese scientific and medical communities, drawn from the universities, research institutes, and hospitals. All communication between these reviewers and the pharmaceutical company is conducted via the Koseisho officer and familiarisation with the file usually takes the Koseisho officer 2 to 3 months. Since the company is not permitted to present data or defend a new drug application (NDA) before the reviewing committees and subcommittees of the CPAC, it is critical that the Koseisho officer be as well versed as possible on the file content. Although the final decision on a drug approval rests with the Minister of Health and Welfare, it would be unusual for the Minister or a Koseisho officer to disagree with the recommendations of the CPAC. The Koseisho officers are not a major part of this decision-making process but fulfill the important role of informed conduits between the company and the committees; therefore these officials cannot enter into any agreements or commitments, pertaining to the scientific evaluations of the application, with a pharmaceutical company during the approval process. |
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