Japan Issues New Regulation to Develop Generic Drug Market

Japan’s Ministry of Health, Labor, and Welfare (MHLW) issued a new regulation on September 22, 2005, which outlined changes in the drug application process for new generic drugs containing one active ingredient. The application will now require pharmaceutical companies that apply for approval of a new generic drug with one active ingredient to state the generic name of the drug, the active ingredient, dosage form, and quantity, as well as the pharmaceutical company name. The previous regulation only required the applicant to list the brand name of the drug, dosage form, and quantity.

Japan ’s generic drug market continues to lag behind that of the U.S. and Europe, due in part to Japanese people’s preference for brand name drugs and the perception that generic drugs are inadequate to their brand name counterparts. Moreover, some Japanese doctors are accustomed to prescribing brand name drugs and would prefer to endorse a widely known patented drug instead of an unfamiliar generic drug. When a doctor writes a prescription for a brand name drug, the pharmacy must issue the specified brand name drug. However, when a doctor writes a prescription using the name of the active ingredient, the pharmacy can choose from the generic drugs it has available. It is hoped that this regulation will help to increase awareness within the medical community that generic drugs contain the same active ingredients as brand name drugs, but cost significantly less. Eventually, both doctors and patients could be encouraged to use generic drugs.

Because the Japanese government is being confronted with rising medical costs, it is seeking lower-priced alternatives in medical care. It hopes to benefit from the new generic drug regulation through the increased usage and reduced costs of generics, as well as from the decreased usage of expensive brand name drugs.