Pharmaceutical Administration and Regulations in Japan - Nihs

preparation of records, etc. as measures
to meet the demands for those requesting
consultations (Notifications 0307001 –
0307007 of the PMDA dated March 7,
2006, partial amendment No. 0330007,
0330004 of the PMDA dated March 30,
2007, No. 0303003 of the PMDA dated
March 3, 2008, Nos. 0331020 and
0331004 dated March 31, 2009, and No.
0621002 of the PMDA dated June 21,
2010,). Prior consultation is also
available to assure smooth face-to-face
advice. Categories of the face-to-face
advice (clinical trial consultations and
simple consultations) handled by the
PMDA are as described below. The
latest information on consultation fees
and application procedures for
face-to-face consultation are available at
the following websites of the PMDA.
* Consultation items and fees:
http://www.pmda.go.jp/operations/sho
nin/info/consult/file/8_tesuryo.pdf
* Application procedures:
http://www.pmda.go.jp/operations/sho
nin/info/consult/taimen.html
(1) Clinical trial consultations
a) Consultations on procedures
b) Consultations on bioequivalence
studies
c) Consultations on safety
Pharmaceutical Regulations in Japan:
d) Consultations on quality
e) Consultations before start of Phase I
studies
f) Consultations before start of early
Phase II studies
g) Consultations before start of late
Phase II studies
h) Consultations after completion of
Phase II studies
i) Consultations before application
j) Consultations when planning clinical
studies for reevaluation and
reexamination
k) Consultations on completion of
clinical studies for reevaluation and
reexamination
l) Additional consultations on drugs
m) Consultations before development
start and application of
non-prescription drugs
n) Consultations on preliminary
assessment of new drugs:
▪ Quality
▪ Nonclinical: Toxicology
▪ Nonclinical: Pharmacology
▪ Nonclinical: Pharmacokinetics
▪ Phase I trials
▪ Phase II trials
o) Consultations on pharmacogenomic
biomarkers for new drugs
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