CMIC, a Tokyo, Japan-based contract research organization, says it has recently obtained a prescription drug marketer license. This allows CMIC, as a designated marketing license holder, to provide pharmaceutical product marketing services to foreign pharmaceutical companies who wish to market their products in addition to the existing services of conducting clinical trials.
In Japan, the revised Pharmaceutical Affairs Law which came into effect in April 2005, requires foreign pharmaceutical manufacturers without a presence there to designate a drug market license holder when they file a New Drug Application for their products with the Ministry of Health, Labor and Welfare. The license holder can be given an approval by product. So far, CMIC has served as an in-country caretaker of clinical trials.
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