Quality & Compliance: Japan’s Drug Lag and National Agenda

Posted 01 January 2011 | By Eriko Tsukamoto, MBA Satish Tripathi, PhD 

Since 1999, a drug called Doxil has been used in 75 countries as the standard treatment for recurrent ovarian cancer. In Japan, however, patients waited nearly 10 years before Doxil received approval and became listed in April 2009. This case is merely one example of how Japan's drug approval lag is adversely affecting its patients, who do not have access to medicines that are marketed in the rest of the world. Japanese patients sometimes must wait for a marketed drug to be approved for a new indication, and at other times they must wait for a drug to become available at all. Drug lag impacts drugs developed in Japan and those developed in other countries and marketed in Japan.

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