Pharmaceutical Administration and Regulations in Japan - Nihs

Reports), and Module 5 (Clinical Study
Reports). Modules 2 to 5 should be
prepared on the basis of the CTD guidelines.
Part 1 consists of documents requested by
each regulatory authority. Detailed
standards are shown in the Appendix.
Electronic specifications for the CTD
(eCTD) have been prepared and have been
applied to application data submitted
electronically since April 1, 2005 (Notification
Nos. 0527004, 0825001, and 0707-(3)
[partially revised] of the Evaluation and
Licensing Division, PFSB dated May 27,
2004, August 25, 2008, and July 7, 2009,
respectively).
In addition to the 1 year standard approval
review time of the MHLW for approval of new
drugs from April 1, 2000 (dated March 28,
2000) (excluding the time taken by applicants
to prepare responses, etc.), the time allotted
to the applicant is also 1 year so that the time
from the application to marketing approval is
a maximum of 2 years. The applicant is
requested by the MHLW to withdraw the
application in case a longer time is required
for responding to inquiries or conducting
additional studies (Notification No. 0604001
of the Evaluation and Licensing Division,
PFSB dated June 4, 2004).
In June 2010, “Points to consider in
applications for shortening the PMDA review
period for new drugs” was issued. This
document includes points to consider on the
Pharmaceutical Regulations in Japan:
applicants side to achieve the target PMDA
review periods of 12 months for ordinary
reviews and 9 months for priority reviews by
2013 (Office Communication of the
Evaluation and Licensing Division and
Compliance and Narcotics Division, PFSB,
MHLW dated June 9, 2010).
On April 17, 2008, “Points to Consider for
Reviewers Related to New Drug Approval
Review Work” was issued. This showed the
basic conditions related to new drug review
activities in the PMDA and was intended to
clarify the main points to consider in reviews
and to assure uniform awareness of PMDA
reviewers concerning review work.
Japanese website:
http://www.pmda.go.jp/topics/h200417koh
yo.html
English website:
http://www.pmda.go.jp/english/services/re
views/others.html
4.3 Priority Review System and
Designation of Drug Products for
Priority Reviews
1) Priority review system
Drug approval reviews are normally
processed in the order that the application
forms are received, but for drugs designated
as orphan drugs and other drugs considered
to be especially important from a medical
standpoint such as new drugs to treat serious
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