Principles and Practice of Pharmaceutical Medicine

10. Data for review as powerful, poisonous
    drug and so on.


11. Draft plan and protocol for PMS.


12. List of attached documentation.


13. Other documents.

ModuleII,Data Summaries (the GAIYO in Japa-
nese), and Module III, Quality, Module IV,
Safety, andModule V, Efficacy, are common to
the ICH Regions. Please refer to the ICH M4
guidelines.
Foreign data attached to the NDA are not neces-
sarily translated in Japanese. They may be sub-
mitted in English, with a Japanese summary; this
is not mandatory however, for original English
entries of the CTD.

Review process

Before submission of the NDA to the Authorities,
the dossier is carefully checked because no other
data, unless specifically required by the MHLW,
can be added after submission. No clinical trial
with the study drug is allowed on Japanese territory

once the review process has started, unless author-

ized by the Authorities.

The application for approval is submitted to the

Health Authorities through the prefectural branch

of the MHLW (Figure 35.6). The 2006 total appli-

cation fees (MHLWþPMDA fees) are ¥16 881 800

(around $140 000) for the first dosage of a new

ethical drug, and ¥4 235 300 for each further

dosage (about $35 000), ¥12 018 400 (around

$100 000) for the first dosage of an orphan drug

and ¥3 011 100 (around $25 000) for each further

dosage, ¥441 300 to 655 300 (around $4 500) for a

generic drug, ¥129 600 (around $1 000) for a non-

prescription drug.

The NDA is transmitted to the PMDAwhich first

conducts a reliability and a GLP compliance

review. When the data quality is confirmed, spe-

cialized team of experts review the NDA data and

prepare a list of requests and questions addressed to

the applicant. After receiving the answers from the

applicant, a review report is prepared. Samples of

the active principle might also be requested, for

analytical control by the National Institute of

Health Sciences.

A meeting with Clinical Experts is then orga-

nized with the review team members of the PMDA

(Specialists Meeting) to discuss key issues of the

PREFECTURE

Office o f New

Drug Review

Team

Interview with

Applicant

PMDA

(SOGO KIKO)

Experts

Review

Meetings

PAFSC

Committees

on New

Drugs

PFSB

Evaluation

&Licensing

Division

PREFECTURE Applicant

MHLW

Filing

Approval

Figure 35.6 Approval process overview

35.5 NEW DRUG APPROVAL PROCESS 503