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adverse-reaction reporting and reexamination among others. Rewritten in 1960, the law subsequently has been revised on several occasions. An official English version of the most recently updated Japanese regulatory process and requirements is available [7]. Revisions, subsequent to the publication of this edition, have as their principal objectives the support of the research and development of orphan drugs and ensurance of earlier approval of highly needed drugs by fast-track examination. These planned activities were calculated to increase the workload of the Koseisho, while it is known that the Japanese government has ruled, some years ago, that there would be no increase in the number of government employees. As a consequence, to ensure that the necessary time would be available to achieve these objectives, a clear reduction of certain aspects of the regulatory work within the Ministry of Health and Welfare (MHW) had to be planned. To this end the MHW has enlisted the assistance of the Lyakuhin Kikou, a nongovernment, nonprofit, public organisation originally established as the instrument through which those who suffer severe drug-related injury could have their cases evaluated and appropriate compensation offered from funding provided by the pharmaceutical industry. The Lyakuhin Kikou is the Japanese for Pharmaceutical Organization and its full title is The Organization for Drug ADR Relief, R & D Promotion and Product Review (Lyakuhin Fukusayo Higai Kynsai Kenkyu Shinkou Chosa Kikou). As part of these drug law revisions of April 1994 the Lyakuhin Kikou, reinforced by the transfer of some Koseisho officers, will review all applications for the registration of generic drugs. Having done so, the Lyakuhin Kikou recommends action to the MHW. Additionally, the Lyakuhin Kikou has been charged with monitoring compliance with Good Laboratory Practice (GLP) and aiding orphan drug development. To this end, it utilises the money it generates from its generic drug evaluation fees. An orphan drug has been defined in Japan as a product that will make a significant contribution to the health and well being of a population of potential patients whose number does not exceed 50,000. The developer can receive significant subsidies and tax benefits. The MHW was assisted by a relaxation of regulations; as of April 1, 1994, all newly approved medications designated for subsequent reexamination and orphan drugs have had the interval from licensing to reexamination extended to 10 years from the previous 6 years. The MHW will further permit the extension of the validity period of the license for the manufacture or importation of drugs from 3 to 5 years and the expansion of items for which approval is not required (e.g., some raw materials). A number of recently approved NCEs have had their reexamination extended to 10 years. |
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The manufacturer of a product deemed essentially identical to an existing one, that is, a me-too product, may submit a New Drug Application (NDA) during the 10 years prior to the reexamination of the original product, but data may be required from the postmarketing surveillance program that is being |
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