Pharmaceutical Administration and Regulations in Japan - Nihs

diseases, a decision must be made whether
or not to specify an overall evaluation of (1)
the seriousness of the targeted disease and
(2) the clinical usefulness, as stipulated in
Article 14-(7) of the Pharmaceutical Affairs
Law. With this system, applications for
specified drugs are reviewed on a priority
basis (Notification No. 0227016 of the
Evaluation and Licensing Division, PFSB
dated February 27, 2004)
(1) Priority review criteria
(A) Seriousness of indicated diseases
(i) Diseases with important effects
on patient’s survival (fatal
diseases)
(ii) Progressive and irreversible
diseases with marked effects on
daily life
(iii) Others
(B) Overall assessment of therapeutic
usefulness
(i) There is no existing method of
treatment.
(ii) Therapeutic usefulness with
respect to existing treatment
a) Standpoint of
efficacy
b) Standpoint of
safety
c) Reduction of
physical and
mental burden
Pharmaceutical Regulations in Japan:
on the patient
(2) Designation of drug products for
priority reviews
When drugs are designated for priority
reviews, opinions of experts on such
designations are compiled by the PMDA
immediately after the application and
reported to the MHLW. Based on this
report, the Evaluation and Licensing
Division decides whether or not to apply
the priority review. The Evaluation and
Licensing Division notifies this decision to
the applicant and the PMDA. The
Evaluation and Licensing Division reports
this application to the next meeting of the
review committee concerned of the
PAFSC and obtains their approval.
Products for priority review are given
priority at each stage of the review
process as much as possible. When
products subject to priority review are
approved as new drugs, this fact is made
public.
2) Review of products designated for
priority face-to-face advice
When products have been designated
for priority face-to-face advice at the
development stage, it is possible to obtain
priority face-to-face advice on indications
and other items concerning the
designated product. Products are
designated on the basis of an overall
evaluation of the seriousness of indicated
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