Pharmaceutical Administration and Regulations in Japan - Nihs

an e-CTD is submitted as the original.
1) Module 1: Administrative information
such as application forms and prescribing
information
(1) Module 1 table of contents (including
table of contents of Module 1)
(2) Approval application (copy)
(3) Certificates (Declarations of those
responsible for collection and
compilation of data for approval
applications, GLP and GCP related
data, contracts for codevelopment
[copies], and declarations required
to be attached in accordance with
Notification No. 0527004 of the
Evaluation and Licensing Division,
PFSB dated May 27, 2004 entitled
“Handling of Computer Formatting of
the Common Technical Document”).
(4) Patent status
(5) Background of origin, discovery, and
development
(6) Data related to conditions of use in
foreign countries, etc.
(7) List of related products
(8) Package insert (draft)
(9) Documents concerning
non-proprietary name
(10) Data for review of designation as
poisons, deleterious substances,
Pharmaceutical Regulations in Japan:
etc.
(11) Draft of basic protocol for
post-marketing surveillance
(12) List of attached documentation
(13) Others
Data related to approved drugs
Clinical trial consultation records
(copies)
Inquiries (copies) and responses
to inquiries (copies)
Other data [data submitted to the
PMDA (copies), data submitted
to the MHLW (copies)
Points to consider in formatting
the eCTD
2) Module 2: Data summaries or CTD
“Gaiyo”
(1) Modules 2 to 5 (CTD) table of
contents
(2) CTD introduction
(3) Quality overall summary
(4) Nonclinical overview
(5) Clinical overview
(6) Nonclinical summary (text and
tables)
Pharmacology
Pharmacokinetics
Toxicity
(7) Clinical summary
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