Pharmaceutical Administration and Regulations in Japan - Nihs

January 28, 2011 entitled “Issuance of
certificates for drugs, quasi drugs and
medical devices for export.” This gives
details including forms for certificates etc. on
certificates on drugs for export (Table 2).
The Office Communications entitled “Q&A
on Handling Notifications for Drugs for
Export” was issued on November 11, 2008.
http://www.pmda.go.jp/operations/shonin/i
nfo/export.html (Japanese website)
5. JAPANESE PHARMACOPOEIA AND
OTHER STANDARDS
5.1 Japanese Pharmacopoeia (JP)
The Japanese Pharmacopoeia (JP) was
established and published to regulate the
properties and qualities of drugs by the
MHLW based on the provisions of Article 41,
Paragraph 1 of the Pharmaceutical Affairs
Law after hearing opinion of the
Pharmaceutical Affairs and Food Sanitation
Council (PAFSC). The JP is a book of drug
standards specified and published by the
Ministry.
Since it was first published in June 1886,
the JP has been revised several times. The
Pharmaceutical Affairs Law specifies that the
JP must be subjected to a complete revision
at least once every 10 years, and such
revisions have actually appeared every 5
years since the 9th revision in April 1976
Pharmaceutical Regulations in Japan:
(Fig. 7. Flowchart of Drug Listing in
Japanese Pharmacopoeia). In addition, the
JP has been partially revised before the
complete revision even 5 years since the
11th Edition.
Japanese website:
http://www.std.pmda.go.jp/jpPUB/index.html
English website:
http://www.std.pmda.go.jp/jpPUB/index_e.ht
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The PAFSC held a meeting of its
Subcommittee on the Japanese
Pharmacopoeia to cope with recent progress
in the medical and pharmaceutical sciences
in November 2001. The basic compilation
policies that include the characteristics and
role of the JP, the actual measures taken for
the 15th edition to achieve the basic policies,
date of enforcement, and items related to the
organization of the Committee on the
Japanese Pharmacopoeia were formulated.
Content regulations including clarification of
significance and specifications of contents
were examined and the JP basic content
regulations were published in a report of the
PAFSC entitled “Future Approaches to the
Japanese Pharmacopoeia.”
Basic compilation policies for the 16th
edition of the JP (Office communication dated
August 3, 2006)
(1) Basic policies
1) Complete entries of all drugs
important in healthcare
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