Pharmaceutical Administration and Regulations in Japan - Nihs

application dossier are required to be
prepared and submitted by the CTD
format.
2.1.2 Non-prescription drugs
The range of data to be submitted with
applications for non-prescription drugs is
specified as shown in Table 4 (Data to be
Submitted with an Application for a
Non-prescription Drug) (partial revision in
Notification No. 0331015 of the PF,dated
March 31, 2005 and Notification No.
1020001 of the PFSB dated October 20,
2008). After complete enforcement of
the CTD (from July 1, 2003), the present
guidelines for preparation of data to be
attached to approval applications can be
applied to approval applications for
non-prescription drugs as in the past.
For the time being, data on the
manufacturing method and specifications
and test methods for non-prescription
drugs with new active ingredients are
prepared using the CTD only for
reference purpose.
3. GUIDELINES CONCERNING DRUG
APPROVAL APPLICATIONS
Guidelines outlining standard test
methods and essential criteria for reference
in the preparation of data for drug
manufacturing and marketing approval
Pharmaceutical Regulations in Japan:
applications have been published in order to
assure efficient and appropriate research and
development. These guidelines have been
prepared on the basis of results of studies
undertaken by groups of experts in the field
concerned.
In recent years, various standards and
guidelines have been established and
implemented according to ICH harmonization
and the reliability and amount of research
data has been internationally harmonized.
To meet demands for more efficient and less
costly development of new drugs,
international utilization of data is on the
increase.
Japan has taken various measures in
keeping with this change in the international
environment, and data from nonclinical
studies such as physicochemical studies,
stability studies and animal studies
performed in foreign countries are accepted,
in principle, if their study designs comply with
the Japanese guidelines.
Two notifications were issued in relation to
the acceptance of foreign clinical data:
“Handling of Data on Clinical trials on Drugs
Performed in Foreign Countries” (Notification
No.739 of the PMSB dated August 11, 1998)
and “Ethnic Factors to be Considered in the
Acceptance of Foreign Clinical Trial Data”
(Notification No. 672 of the Evaluation and
Licensing Division, Pharmaceutical and
Medical Safety Bureau dated August 11,
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