Pharmaceutical Administration and Regulations in Japan - Nihs

8) GCP
The first GCP, Standards for Conduct
of Clinical Trials on Drugs, intended to
assure that clinical studies are performed
on the basis of ethical considerations and
from the proper scientific standpoint were
issued as Notification No 874 of the PAB
dated October 2, 1989, and this GCP was
applied in the form of administrative
guidance from October 1, 1990.
Thereafter, the MHW undertook various
studies to improve the quality of clinical
studies in Japan in accordance with
changes in the international regulatory
situation, and a new GCP was issued as
an MHW ordinance (No.28, March 27,
1997) based on a report of the Central
Pharmaceutical Affairs Council (March 13,
1997). This new GCP, which is legally
binding, went into effect from April 1,
1997.
The old GCP consisted mainly of
provisions concerning pharmaceutical
companies as the sponsors of clinical
studies, but the new GCP clarifies and
reinforces the role and responsibilities of
sponsors, and also includes provisions
concerning the medical institutions and
investigators (physicians) performing the
clinical studies.
Further, the GCP was revised to
expand its scope to cover clinical trials
conducted by the physician or medical
Pharmaceutical Regulations in Japan:
institution for approval application in order
to manage clinical trials similarly to the
current clinical trial system. The revised
GCP was enacted by the Ordinance for
Partial Revision of the Standards for the
Conduct of Clinical Trials on Drugs
(Notification No. 106 issued by the MHLW
on June 12, 2003) and enforced on April 1,
2005 by the Ordinance for Partial
Revision of the Standards for the Conduct
of Clinical Trials on Drugs (Notification No.
172 issued by the MHLW on December
21, 2004). The GCP was further revised
to improve the quality and function of the
investigational review board (Ordinance
for Partial Revision of the Standards for
the Conduct of Clinical Trials on Drugs
(Notification No. 72 issued by the MHLW
on March 31, 2006).
The MHLW Council of Ideal
Registration-Directed Clinical Trials
discussed ways and means of institutional
review boards and notification of adverse
drug reactions, etc. to medical institutions
performing clinical studies, etc. and
compiled a report of recommendations on
September 19, 2007. The report was
adopted (MHLW Ordinance No. 24 of
February 29, 2008) and enforced from
April 1, 2008 (partially enforced on April 1,
2009).
This GCP consists of six chapters and
59 articles. It has three main parts:
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