MHLW To Erase Drug Lag By 2011 And Oppose Reference Price System
This article was originally published in PharmAsia News
Executive Summary
Japan's Ministry of Health, Labor and Welfare issued a report Aug. 12 on measures to erase the Japanese drug lag and promote generic drug use. In the report, the Ministry set a goal of erasing the drug lag by 2011. To reach this goal, the MHLW plans to increase the number of reviewing staff and improve its Good Clinical Practice operations. However, the Ministry denies that it will significantly relax approval regulations on new drugs that have already been approved in the U.S. and Europe. According to the Ministry, a sufficient approval reviewing process is needed as ethnic differences exist, such as Japanese need lower dosages and show more severe adverse effects compared to Europeans and Americans. In generic drugs use, the Ministry also declined to introduce a reference price system, in which insurance reimbursements prices for the brand and for generic drugs are kept the same when the patent for a branded drug expires. (Click here for more - Japanese language
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