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| home > epc > spring 2002 > clinical trials and new drug applications in japan |
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European Pharmaceutical Contractor
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The Common Technical Document (CTD) is a major step towards internationally recognised marketing authorisation applications, but its success will be affected by processes at a national level. In Japan, a number of recent clinical, ethical, regulatory and review changes also serve to provide even better access to this important region.
There has been considerable change in the Japanese regulatory framework over the last five years or so, driven by external (ICH) and internal (government) factors. The result is more effective, transparent and manageable approval processes.
With a population of 125 million (1), a recent international agreement on the CTD, and significant inclusion of other ICH steps, Japan represents a sizeable and accessible marketplace for research and marketing - more than ever before. In the mid- to late nineties, in excess of 7,000 ethical, over-the-counter (OTC) and quasi-drug manufacturing licences were held in Japan (1,2). With that in mind, the essential steps to obtain approval for clinical trials and to obtain marketing authorisation are described below.
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