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Japan's PMDA looks to the future as it balances access and safety

This article was originally published in Scrip

Executive Summary

Since it was set up in April 2004, bringing together drug and medical device regulatory functions then split between various government bodies, the PMDA has not always elicited the kindest of comments from applicants. Frustrations have sometimes been expressed at review times, procedures and difficulties finding slots for consultations. But things have improved markedly over the last few years and the tone of comments one now hears from industry has become much more positive.

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