A generic drug is a drug in which the patent term relating to the active ingredient has expired. Under the Pharmaceutical Affairs Act, the approval of the Ministry of Health, Labour and Welfare (the MHLW) is required for any manufacture and marketing of drugs, and as a matter of course, the same rule would be applicable to generic drugs. Although the application procedure for the approval of generic drugs is easier than that for the approval of new drugs, generic drugs are subject to certain restrictions.