Pharmaceutical Administration and Regulations in Japan - Nihs

the safety of drugs, the reliability of the
data should be assured so that the results
obtained are correctly analyzed and
assessed. For this purpose, all toxicity
tests conducted to support applications
for new drug manufacturing and
marketing approval and reexamination
must be conducted in accordance with the
Good Laboratory Practice Standards for
Safety Studies on Drugs (GLP).
(Notification No. 902 of the Evaluation
and Licensing Division, PFSB dated June
21, 2001 requires safety pharmacology
studies be performed in accordance with
the “Guidelines on Safety Pharmacology
Studies” to comply with the GLP
Ordinance.)
Following the introduction of the GLP
requirements in the US, the Japan
Pharmaceutical Manufacturers
Association started to prepare a draft of
its voluntary GLP guidelines in 1976. In
1978, the MHW established the GLP
Committee. The first GLP requirements
in Japan were published in March 1982
and enforced in April 1983. They were
partially revised and updated in October
1988.
Thereafter, the GLP Guidelines, which
had formerly been in the form of a MHLW
bureau notification were legalized as the
MHW Ordinance on Standards for
Implementation of nonclinical Studies on
Pharmaceutical Regulations in Japan:
Safety of Drugs (Ordinance No.21, March
26, 1997, partially revised by Notification
No. 127 of the MHLW Ordinance dated
October 20, 2000) (GLP) in order to
assure greater reliability than previously
of the nonclinical safety data. After
partial revision by Ordinance No. 114
dated June 13, 2008, this new GLP was
enforced on August 15, 2008.
Compared with the previous GLP, the
MHW Ordinance GLP stipulates various
responsibilities, including that of the
sponsor when requesting outside facilities
to perform nonclinical studies. The
ordinance requires establishment and
defines the responsibilities of Quality
Assurance Units, the obligation of the
management of testing facilities to
prepare standard operating procedures
(SOP) containing test methods and
procedures, and the obligation of study
directors to prepare study protocols and
final reports.
This ordinance consists of eight
chapters and 19 articles as outlined
below:
Chapter 1 (Articles 1-4)
Purpose of this ordinance, definition of
terms, responsibilities of sponsors
Chapter 2 (Article 5-8)
Responsibilities of management of
testing facilities, study directors and
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