Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
Pharmaceutical Administration and Regulations in Japan - Nihs
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the Inspection <strong>and</strong> Guidance Division, PMSB<br />
dated June 30, 1999); <strong>and</strong> for ways to reduce<br />
the f<strong>in</strong>ancial burden on study centers,<br />
<strong>in</strong>clud<strong>in</strong>g national hospitals <strong>and</strong> national<br />
universities (Notification No. 196 of the<br />
Medical Professions Division, Health Policy<br />
Bureau dated July 2, 1999 <strong>and</strong> Notification<br />
No. 20 of the Medical Education Division,<br />
Higher Education Bureau, M<strong>in</strong>istry of<br />
Education, Culture, Sports, Science <strong>and</strong><br />
Technology dated July 2, 1999).<br />
The new GCP was enacted on October 4,<br />
1998. However, the Study Group on the<br />
Efficient Conduct of Cl<strong>in</strong>ical Trials <strong>in</strong>dicated<br />
the need for st<strong>and</strong>ard operat<strong>in</strong>g procedures<br />
(SOP) for the proper conduct of cl<strong>in</strong>ical<br />
studies. One of the work<strong>in</strong>g groups started<br />
to <strong>in</strong>vestigate st<strong>and</strong>ard operat<strong>in</strong>g procedures,<br />
<strong>in</strong> particular the acceptance of monitor<strong>in</strong>g<br />
<strong>and</strong> audits by medical <strong>in</strong>stitutions that<br />
presents a problem <strong>in</strong> cl<strong>in</strong>ical practice<br />
(Notification No. 889 of the Evaluation <strong>and</strong><br />
Licens<strong>in</strong>g Division, PMSB dated July 24,<br />
2000). Because of <strong>in</strong>creas<strong>in</strong>g use of site<br />
management organizations (SMOs) for<br />
cl<strong>in</strong>ical trials <strong>in</strong> medical <strong>in</strong>stitutions, the<br />
Report of the SOP Study Group on Utilization<br />
of SMO was published <strong>in</strong> November 2002.<br />
Part of the revision of the <strong>Pharmaceutical</strong><br />
Affairs Law <strong>in</strong> July 2002 came <strong>in</strong>to effect <strong>in</strong><br />
2003. This <strong>in</strong>cluded the establishment of a<br />
system for cl<strong>in</strong>ical studies performed for<br />
future approval applications by physicians<br />
<strong>Pharmaceutical</strong> <strong>Regulations</strong> <strong>in</strong> <strong>Japan</strong>:<br />
<strong>and</strong> medical <strong>in</strong>stitutions (so-called<br />
<strong>in</strong>vestigator-<strong>in</strong>itiated cl<strong>in</strong>ical trials). It has<br />
become possible to conduct cl<strong>in</strong>ical studies<br />
on unapproved drugs obta<strong>in</strong>ed by physicians<br />
<strong>and</strong> medical <strong>in</strong>stitutions <strong>and</strong> cl<strong>in</strong>ical studies<br />
on off-label applications of approved drugs<br />
(MHLW Ord<strong>in</strong>ance No. 106 dated June 12,<br />
2003, the “revised GCP”). Application of the<br />
revised GCP is specified <strong>in</strong> Notification No.<br />
0722014 of the Evaluation <strong>and</strong> Licens<strong>in</strong>g<br />
Division, PFSB dated July 22, 2004. In<br />
March 2005, the Council on Efficient Conduct<br />
of Cl<strong>in</strong>ical Trials was established to evaluate<br />
<strong>and</strong> f<strong>in</strong>d ways to efficiently conduct cl<strong>in</strong>ical<br />
trials assur<strong>in</strong>g reliability of the conduct of<br />
cl<strong>in</strong>ical trials <strong>and</strong> safety of study subjects <strong>and</strong><br />
discussed procedures necessary for proper<br />
conduct of <strong>in</strong>vestigator-<strong>in</strong>itiated cl<strong>in</strong>ical trials<br />
<strong>and</strong> for improvement of quality <strong>and</strong><br />
performance of <strong>in</strong>stitutional review board.<br />
On September 19, 2007, a report was<br />
compiled by the MHLW Council of Ideal<br />
Registration-Directed Cl<strong>in</strong>ical Trials. Based<br />
on this report, the Evaluation <strong>and</strong> Licens<strong>in</strong>g<br />
Division of PFSB issued Notification No.<br />
1002002 dated October 2, 2007 to reevaluate<br />
<strong>and</strong> rationalize the type <strong>and</strong> scope of<br />
documents necessary for the conduct of<br />
cl<strong>in</strong>ical trials.<br />
The GCP ord<strong>in</strong>ance was partially revised<br />
by MHLW Ord<strong>in</strong>ance No. 24, 2008 entitled<br />
“MHLW Ord<strong>in</strong>ance to Partially Amend the<br />
MHLW Ordnance on St<strong>and</strong>ards for<br />
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