do not readily accept Japanese clinical trials. As long as such problems persist, Japanese pharmaceutical companies will have to conduct clinical trials overseas-often through licensing or joint ventures-to deal with regulatory obstacles. The international harmonization of regulatory standards will ease these difficulties.ConclusionOur decision is to decline the opportunity of exporting medical drugs to Japan. The reasons are: 1.too many regulations,2.duties, 3.fees, and 4.barriers that sway us away from the ability to compete against the companies that already have an existing alliance with Japan.If these companies did not already exist, our company would have the opportunity to consider advancing Japans medical technology. We do however, than have to face the difficulties that Japan sets forth on us dealing with their various obstacles that we have to overcome.Additional Issues:5.to raise our prices by 200 percent above the base price would lead to no earnings no profit an impossibility for Japan to consider working with the U.S....