Pharmaceutical Administration and Regulations in Japan - Nihs

international harmonization of approval
review data for new drugs.
This notification consists of the
objective of the guidelines, general
principles (protection of clinical trial
subjects and scientific approach in design
and analysis) and development methods
(points to consider for development plans
and for individual clinical studies).
In order to protect the study subjects
these Guidelines specify that, as a
condition to start a clinical study, the
safety of the drug must be shown from
nonclinical studies or previous human
studies. Throughout drug development,
qualified clinicians and other experts
should review and evaluate all newly
obtained data from toxicity studies on
animals and human studies to assess
their implications for the safety of the
subjects.
Clinical studies should be designed,
conducted, and analyzed in keeping with
sound scientific principles in order to
achieve their objectives, and they should
be reported appropriately. The essence
of rational drug development is to pose
important questions and answer them
with the results of carefully controlled
clinical studies. The primary objectives
of any study should be clear and explicitly
stated.
Clinical studies can be classified by
Pharmaceutical Regulations in Japan:
their objectives. The basic logic behind
serially conducted studies of a drug is that
the results of prior studies should
influence the protocols of later studies
(Table 5. Classification of Clinical Studies
According to Objectives).
Following an ICH agreement to issue
common GCP for scientific and ethical
conduct of clinical studies in three regions,
the MHLW Ordinance on Standards for
Implementation of Clinical Studies on
Drugs (GCP) (MHW Ordinance No. 28
dated March 27, 1997, partial revision by
MHLW Ordinance No. 106 dated June 12,
2003, MHLW Ordinance No. 172 dated
December 21, 2004, MHLW Ordinance
No. 72 dated March 31, 2006, and MHLW
Ordinance No. 24 dated February 29,
2008) was issued with the aims of
specifying the requirements for the
planning, conduct, monitoring, auditing,
records, analysis, and reports of clinical
studies performed to collect data to be
submitted with applications for approval to
manufacture and market drugs; to protect
the human rights, safety, and welfare of
study subjects; and to assure the
scientific quality of the study and the
reliability of its results.
The Evaluation and Licensing Division
of the PMSB issued a notification (No.
889 dated July 24, 2000) on the topic of
monitoring and audits to promote and
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