Pharmaceutical Administration and Regulations in Japan - Nihs

Approval of Manufacturing/Marketing of
Medicinal Products” (partially revised by
Office Communication on April 22, 2005 and
on non-prescription drugs partially revised by
Notification No. 1020002 of the Evaluation
and Licensing Division, PFSB dated October
20, 2008).
Subsequently, an agreement was reached
on the Common Technical Document (CTD)
by the ICH (International Conference on
Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human
Use) and a notification entitled “Handling
Data Attached to Drug Approval Applications”
(Notification No. 663 of the PMSB, MHLW
dated June 21, 2001), which is a partial
revision of the previous notification
mentioned above. On the same day,
another notification entitled the “Guidelines
for Preparation of Data Attached to
Applications for Approval to Manufacture or
Import New Drugs” (Notification No. 899 of
the Evaluation and Licensing Division,
PMSB, dated June 21, 2001, partially revised
by Notification No. 0701004 of the Evaluation
and Licensing Division, PFSB, dated July 1,
2003, Notification No. 0525003 of the
Evaluation and Licensing Division, PFSB
dated May 25, 2004, Office Communication
dated May 24, 2004, and Notification No.
0707-(3) of the Evaluation and Licensing
Division, PFSB dated July 7, 2009) was
issued to specify guidelines for preparation of
Pharmaceutical Regulations in Japan:
data to be attached to approval applications
based on the CTD. The data required for
approval applications using CTD format is
shown below. The data in Modules 2 to 5
are prepared on the basis of the CTD
guidelines shown in Attachments 1 and 3 to 5
of these guidelines.
For electronic specifications of the CTD
(e-CTD), “Electronic Specifications of the
Common Technical Document” (Notification
No. 06404001 of the PFSB dated June 4,
2003, partially revised by Notifications No.
0527001 of the Evaluation and Licensing
Division, PFSB dated May 27, 2004, No.
0527004, 0825001, and 0707-(3) dated
August 25, 2008, and July 7, 2009,
respectively). These specifications were
enforced from October 1, 2008. Handling of
submissions of electronic data and Q&A are
shown in the Handling of Electronic
Specifications for Common Technical
Documents (Notification No. 0527004 of the
Evaluation and Licensing Division, PMSB
dated May 27, 2004, partially revised by
Notification No. 0707-(3) of the Evaluation
and Licensing Division, PMSB dated July 7,
2009), Office Communications dated March
31, 2005, April 27, 2005, October 5, 2006,
December 22, 2006, July 7, 2009, and
February 26, 2010. In Japan, submission of
eCTD is not obligatory but it is
recommended. It is no longer necessary to
submit paper data for approval applications if
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