Pharmaceutical Administration and Regulations in Japan - Nihs

trial sponsors (Article 59). However,
since the scope of application differs
from that of the standards related to
approval review data, certain
provisions for clinical trials for new
drug application are applied for
those for reexamination and the
required changes in reading shall be
made accordingly in this article.
Clinical trials performed to obtain data
for approval applications must be
conducted, results collected and data
prepared in accordance with the GCP.
In addition to clinical trials sponsored by
companies, it is also possible for
investigator-initiated clinical trials to be
performed for the preparation of approval
application data in compliance with the
GCP. With the legalization of the GCP
standards, data from clinical trials subject
to the GCP will not be accepted as
approval application data unless the trial
was conducted and the data collected and
prepared in accordance with the GCP.
Application data from clinical trials
submitted to the MHLW must first
undergo a GCP compliance review to
assure that it meets GCP standards.
This review consists of a paper inspection
and on-site inspection at the medical
institution(s) performing the trial, etc.
The review is intended to confirm the
Pharmaceutical Regulations in Japan:
reliability of the data as application data.
These GCP compliance reviews are
performed by the PMDA at the request of
the MHLW for data collected and
prepared in Japan. The approval review
is then undertaken by the MHLW in
accordance with the results of PMDA
review.
The on-site inspections are performed
at both the sponsor's facilities and the
medical institution(s) performing the trial.
Inspections of the sponsor's facilities
examine the organization, structure and
management of the GCP-related division,
GCP compliance of clinical trials and
confirmation of the items included in the
trial results. Inspections in the medical
institutions review the outline of the
facilities and organization, the structure
and operation of the IRB, GCP
compliance of the clinical trial, and items
in the case report forms.
9) Investigational Product GMP
In Article 17, Supply of the
Investigational Product, in the GCP
ordinance, it specifies that the sponsor
shall supply to the medical institution
performing the study investigational
product manufactured in factories
applying appropriate manufacturing
control and quality control methods and
with the buildings and facilities required to
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