Pharmaceutical Administration and Regulations in Japan - Nihs

Information on approval reviews for new
drugs is provided on the following websites:
Japanese:
http://www.info.pmda.go.jp/info/syounin_i
ndex.html
English (part of product items):
http://www.pmda.go.jp/english/service/revi
ew.html
“A Joint Position on the Disclosure of
Clinical Trial Information via Clinical Trial
Registries and Databases” was issued on
January 6, 2005 as a joint communiqué by
four organizations: International Federation
of Pharmaceutical Manufacturers
Associations (IFPMA), Pharmaceutical
Research and Manufacturers of America
(PhRMA), European Federation of
Pharmaceutical Industry Associations
(EFPIA) and Japan Pharmaceutical
Manufacturers Association (JPMA). The
communiqué declared that registration for all
clinical trials except exploratory studies must
be disclosed and information on the results of
all studies (except exploratory studies) on
drugs approved or marketed in at least one
foreign country must be disclosed.
Based on this declaration, the Ministry of
Education, Culture, Sports, Science and
Technology in Japan initiated the UMIN
Clinical Trial Registration System
(UMIN-CTR;
http://www.umin.ac.jp/ctr/index-j.htm) and the
Pharmaceutical Regulations in Japan:
MHLW publishes information concerning
nonclinical trials via “Clinical trial information”
(http://www.japic.or.jp/index.html), a
database for registration and disclosure of
clinical trial information through cooperation
with the Japan Pharmaceutical Information
Center and JPMA.
Using these systems, pharmaceutical
companies disclose information nonclinical
trials with adequate consideration given to
privacy of individual subjects, intellectual
property rights, and contractual rights in order
to improve the transparency of clinical trials.
In a system unique to Japan, information
on institutional review boards is made public
voluntarily (Notification No 1001013 of the
Evaluation and Licensing Division, PMSB
dated October 1, 2008 and Office
Communication dated April 2, 2009).
5.5 ICH (International Conference on
Harmonization of Technical
Requirements for Registration of
Pharmaceuticals for Human Use)
ICH policies are drafted by a steering
committee consisting of members from six
groups, namely regulatory authorities and
pharmaceutical industry organizations in the
EU, Japan, and the United States.
Members include the Food and Drug
Administration (FDA), Pharmaceutical
Research and Manufacturers of America
(PhRMA), the European Medicines Agency
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