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Japan’s PMDA Introduces Data Mining To Detect Adverse Events Earlier

This article was originally published in PharmAsia News

Executive Summary

Starting in fiscal year 2009, the Pharmaceuticals and Medical Device Agency of Japan plans to experiment with data mining techniques to detect earlier safety issues in drugs and medical devices. As a key element of a safety assurance system introduced in 2004, data mining will be used to understand drug risks at early stages and to prevent expansion of adverse events. PMDA said that the data mining system has been completed, and that a new adverse event database will also launch in 2009. Data mining has been used by the U.S. FDA and World Health Organization. (Click here for more - Japanese language



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