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Drug approvals and pharmaceutical affairs in Japan
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08/03/05
Notification No. 1831
Filed under: Key documents
Posted by: Kanri @ 5:05 am

Quite a few of our customers are trying to use the search engine of the www.jouhoukoukai.com web site to retrieve Japanese regulatory documents. Recently, a user queried the site for a particular document until exhausted all possible syntax combinations:

The search has ended with “not found” but not because of the information regarding the “Notification No. 1831” is not available or the queries were not diligent. Until 2000 the Pharmaceutical Affairs Bureau (PAB) and its successors from 1997 - the Pharmaceutical and Medical Safety Bureau (PMSB), and from 2001 - the Pharmaceutical and Food Safety Bureau (PFSB) simply numbered the released documents in order of issuing what resulted in non-descriptive document numbers such as “1831”, and hence now there are two – completely unrelated documents under one and the same number (1831) and distinguished only by the title and date of issue. The older PMSB/ELD Notification No. 1831 (dated December 17, 1999) is entitled “On the Guidelines Concerning Clinical Studies of Medicinal Products in Pediatric Group (draft)”, while the more recent one of December 27, 2000 is on “Revision of the Guideline for Timing of Preclinical Studies in Relation to Clinical Trials”.

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