Pharmaceutical Administration and Regulations in Japan - Nihs

the Inspection and Guidance Division, PMSB
dated June 30, 1999); and for ways to reduce
the financial burden on study centers,
including national hospitals and national
universities (Notification No. 196 of the
Medical Professions Division, Health Policy
Bureau dated July 2, 1999 and Notification
No. 20 of the Medical Education Division,
Higher Education Bureau, Ministry of
Education, Culture, Sports, Science and
Technology dated July 2, 1999).
The new GCP was enacted on October 4,
1998. However, the Study Group on the
Efficient Conduct of Clinical Trials indicated
the need for standard operating procedures
(SOP) for the proper conduct of clinical
studies. One of the working groups started
to investigate standard operating procedures,
in particular the acceptance of monitoring
and audits by medical institutions that
presents a problem in clinical practice
(Notification No. 889 of the Evaluation and
Licensing Division, PMSB dated July 24,
2000). Because of increasing use of site
management organizations (SMOs) for
clinical trials in medical institutions, the
Report of the SOP Study Group on Utilization
of SMO was published in November 2002.
Part of the revision of the Pharmaceutical
Affairs Law in July 2002 came into effect in
2003. This included the establishment of a
system for clinical studies performed for
future approval applications by physicians
Pharmaceutical Regulations in Japan:
and medical institutions (so-called
investigator-initiated clinical trials). It has
become possible to conduct clinical studies
on unapproved drugs obtained by physicians
and medical institutions and clinical studies
on off-label applications of approved drugs
(MHLW Ordinance No. 106 dated June 12,
2003, the “revised GCP”). Application of the
revised GCP is specified in Notification No.
0722014 of the Evaluation and Licensing
Division, PFSB dated July 22, 2004. In
March 2005, the Council on Efficient Conduct
of Clinical Trials was established to evaluate
and find ways to efficiently conduct clinical
trials assuring reliability of the conduct of
clinical trials and safety of study subjects and
discussed procedures necessary for proper
conduct of investigator-initiated clinical trials
and for improvement of quality and
performance of institutional review board.
On September 19, 2007, a report was
compiled by the MHLW Council of Ideal
Registration-Directed Clinical Trials. Based
on this report, the Evaluation and Licensing
Division of PFSB issued Notification No.
1002002 dated October 2, 2007 to reevaluate
and rationalize the type and scope of
documents necessary for the conduct of
clinical trials.
The GCP ordinance was partially revised
by MHLW Ordinance No. 24, 2008 entitled
“MHLW Ordinance to Partially Amend the
MHLW Ordnance on Standards for
2011-3 - 31 -