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Clinical Trials and New Drug Applications in Japan

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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By Tony Mitchell, Director of Regulatory Affairs at Origin Pharmaceutical Services Limited

Dr Tony Mitchell is Director of Regulatory Affairs and Strategic Services at Origin Pharmaceutical Services Limited.

He has considerable experience in the international registration of pharmaceutical products. He previously held regulatory positions at Fisons Pharmaceuticals, British Biotech Pharmaceuticals Limited and Pharmakopius, the international contract research organisation.

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Dr Tony Mitchell
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