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DewDiligence

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DewDiligence

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Re: ghmm post# 41995

Monday, 02/12/2007 8:16:38 PM

Monday, February 12, 2007 8:16:38 PM

Post# of 253594
Re: Japanese drug reviews

>Anybody know anything about the Japanese regulatory process? Are they like the US with a (more or less) fixed time frame for review…<

The Japanese agency that regulates drugs is the Ministry of Health, Labor, and Welfare (MHLW). They are much more understaffed than the FDA and consequently drug reviews can seemingly go on forever.

>…if so how long is the process from submission or is it open-ended?<

See above.

>…do they have an expedited review process of some sort?<

In very rare cases, MHLW will fast track an application. For instance, they recently did this with Roche’s Copegus (ribavirin) for HCV.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
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