Pharmaceutical Administration and Regulations in Japan - Nihs

1998 and partial revision by Office
Communication dated January 4, 1999) and
its Q and A (Office Communications dated
February 25, 2004 and October 5, 2006).
According to these notifications, when data
from clinical studies performed in foreign
countries are used for new drug application in
Japan, the data is first checked to assure that
it complies with legal requirements in Japan.
Whether or not the drug is apt to be affected
by ethnic factors (intrinsic or extrinsic factors)
is then evaluated. When necessary, a
bridging study is performed, and when it is
concluded that the clinical study outcome in a
foreign population can be extrapolated to the
Japanese population, the foreign data can be
accepted. Since the possibility of
acceptance is actually left up to the
authorities concerned, this topic is often part
of the consultations on clinical studies
undertaken by the PMDA.
It is necessary to promote global clinical
trials to achieve more efficient and rapid
development of new drugs to eliminate drug
lag in which the approval timing of new drugs
is several years behind that in other
countries. Therefore, basic concepts
related to global clinical trials have been
compiled (Notification No. 0928010 of the
Evaluation and Licensing Division, PFSB
dated September 28, 2007).
Marketed drugs that have been used for
unapproved indications or dosage and
Pharmaceutical Regulations in Japan:
administration in clinical practice (off-label
use) should be used appropriately by
receiving marketing approval based on the
Pharmaceutical Affairs Law. But in the
cases the indications and dosage and
administration related to off-label use are
confirmed by medical and pharmaceutical
knowledge in the public domain, a judgment
is made of whether or not the use can be
approved without performing all or part of the
clinical trials again (Notifications No. 4 of the
Research and Development Division, Health
Policy Bureau and No. 104 of the Evaluation
and Licensing Division, Pharmaceutical and
Medical Safety Bureau dated February 1,
1999). After this notification was issued,
applications based on public knowledge have
been filed and approved.
(1) Cases where an official approval of
indication(s) unapproved in Japan has
already been granted overseas (countries
with approval systems confirmed to be on the
same level as the system in Japan or with
corresponding systems; the same
hereinafter), sufficient experience of use in
medical practice is available, and data
appended to the application for the regulatory
authorities can be obtained.
(2) Cases where an official approval
indication(s) unapproved in Japan has
already been granted overseas, sufficient
experience of use in medical practice is
available, scientific evidence has been
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