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referees was designed as part of the same process. However, with the resultant pressure for publication and subsequent registration, non-peer-review journals created a niche in the market place by speedily publishing all that was submitted. Another point of note is that in the NDA, all the data must be presented in Japanese. Translation, if necessary, must be done with care to ensure scientific accuracy of the data and its interpretation. All translations must be accompanied by a copy in the original language. Translation of large dossiers is both time consuming and very expensive. All copies of every data report supporting an application for approval to manufacture or import a drug must bear an original signature of the person who conducted the tests, and, to verify his or her qualifications, a copy of that person's curriculum vitae must be included. The suitability of all institutions supplying test results must also be verified by submission of detailed statements, including a full floor plan, indicating all equipment and its layout [11]. Considerably more detail than required for other regulatory agencies is necessary and includes the origin, details of discovery, and the process of development of the drug. To evaluate possible novelty in comparison to other drugs in the same therapeutic class, the sponsor must submit a tabulation of such features as dosage and administration, warnings, precautions, and adverse reactions. These data are to be gleaned from the company's worldwide development program, which is somewhat surprising given the weight placed on local Japanese comparative studies. A vital part of a Japanese NDA is the highly condensed summary of approximately 200 pages. |
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Data requirements for assessing the physicochemical properties, standards, and test methods must include the demonstration of the molecular structure of the active substance and quality-control specifications for the active substance. To demonstrate uniformity of the production process, results from the testing of at least five lots of new drug substance and of the finished product must be submitted, and each quantitative test has to be conducted in triplicate. This multiplicity of testing to set product specifications creates a heavy workload and may ignore an extensive database developed outside of Japan. Although the Koseisho is now slowly accepting data generated to its protocols outside of Japan [12], this does not resolve the issue of potential, substantial duplication of data generated elsewhere for a protocol not requiring the same degree of repetition. |
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The guidelines for stability testing were amended in 1991 [13] and further amended for medicines containing an NCE in 1994 [14]; their differences from those of the United States have been reviewed [15]. The expiration dating of a product is based on real-time storage testing. However, the Koseisho will |
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