Pharmaceutical Administration and Regulations in Japan - Nihs

Pharmaceuticals (ICH S2B)
(Notification No. 554 of the
Evaluation and Licensing Division,
PMSB dated July 9, 1998)
(12) The non-clinical evaluation of the
potential for delayed ventricular
repolarization (QT interval
prolongation) by human
pharmaceuticals (ICH S7B)
(Notification No. 1023-(4) of the
Evaluation and Licensing Division,
PMSB dated October 23, 2009)
(13) Immunotoxicity Studies for Human
Pharmaceuticals (ICH S8)
(Notification No. 0418001 of the
Evaluation and Licensing Division,
PMSB dated April 18, 2006)
Data on the following studies that
should be conducted in accordance with
the above guidelines are required for the
review and evaluation of a new drug
application by the Ministry (Table 3:
Documentation that must be submitted
with application for marketing approval of
prescription drugs):
(1) Single dose toxicity studies
(2) Repeated dose toxicity studies
(3) Genotoxicity studies
(4) Carcinogenicity studies
(5) Reproductive and developmental
toxicity studies
(6) Skin irritation studies
(7) Other toxicity studies
Pharmaceutical Regulations in Japan:
Drug dependence studies were
specified separately from the toxicity
guidelines in the Scope of Application and
the Guidelines for Animal Studies and
Clinical Observations on Drug
Dependence (Notification No. 113 of the
Narcotics Division, PAB dated March 14,
1975) and the Guidelines for Animal
Studies and Clinical Observations on
Drug Dependence (Notification No. 383 of
the Narcotics Division, PAB dated June 7,
1978).
For biological products, the guideline
“Nonclinical Safety Evaluation of
Biotechnological Drugs” (ICH S6)
(Notification No. 326 of the Evaluation
and Licensing Division, PMSB dated
February 22, 2000) should be referred to.
For infection prophylactic vaccines, refer
to the guideline “Nonclinical safety
evaluation of prophylactic vaccines
(Notification No. 0527-(1) of the the
Evaluation and Licensing Division, PMSB
dated May 27, 2010) and for
anti-malignant tumor agents, refer to the
guideline “Nonclinical safety evaluation of
anti-malignant tumor agents (Notification
No. 0604-(1) of the the Evaluation and
Licensing Division, PMSB dated June 4,
2010).
4) Good Laboratory Practice (GLP)
For toxicity tests conducted to confirm
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