MHLW Relied On EU and U.S. For Actos Safety Data, But Newly Funded Health Records Database Will Boost Japan's Pharmacovigilance
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Japan's Ministry of Health, Labor and Welfare followed the lead of EMA and U.S. FDA and requested Takeda Pharmaceutical Co. Ltd. to change labeling for Actos (pioglitazone) to reflect safety concerns about the risk of bladder cancer. MHLW had to rely on epidemiological data compiled by EMA, but MHLW's safety division hopes new funding from the government will help build an electronic health records database to conduct similar pharmacovigilance epidemiology studies for the Japanese market