PSEHB Notification No.

0307-3
March 7, 2016

Each prefectural governor

Director General of Pharmaceutical Safety

and Environmental Health Bureau,
Ministry of Health, Labour and Welfare
(Official seal omitted)

About the formulation of the Japanese Pharmacopoeia Seventeenth Edition, etc.

The Japanese Pharmacopoeia Seventeenth Edition (hereinafter referred to as “new

Pharmacopoeia”.) is issued according to the “Comprehensive revision of the Japanese
Pharmacopoeia” (The Ministry of Health, Labour and Welfare Ministerial Notification No. 64,
2016), and it shall be applied on April 1, 2016. Please be aware of the following items and carry
out the knowledge and guidance to the people concerned.

Record

I. Key points of new Pharmacopoeia

Necessary improvement is conducted for the new Pharmacopoeia based on “Basic principles
for the formulation of the Japanese Pharmacopoeia Seventeenth Edition” ( The report of the
Pharmaceutical Affairs and Food Sanitation Council on July 13, 2011) for adapting to the
improvement of medicine and pharmacy, and harmonizing with the standards of other nations.
Besides “Preface”, key points of the new Pharmacopoeia also include the following content,
which should be paid attention to.

1 In the new Pharmacopoeia, The text referred to by the term “as follows” are omitted in the
official bulletin and made available for public exhibition at each Prefectural Office in Japan
refers to General Notice, General Rules for Crude Drugs, General Rules for Preparations,
General Tests, Drug Monographs, Ultraviolet-visible Reference Spectra and Infrared
Reference Spectra.

2 General Notice is described as follows.

(1) In Paragraph 5, Containers under ``Containers and storage'' in the monograph on
preparations（except preparations containing crude drugs as main active ingredients）
were removed from the standards for conformity）.
 (2) The following regulations are newly added to Paragraph 12.
From the point of view of quality assurance, requirements that should be noted on
manufacturing processes, if appropriate in addition to the specifications, are shown in
the heading “Manufacture” in monograph. It may contain requirements regarding
control of materials, manufacturing processes and intermediates, and requirements
regarding tests in process and omission of tests for the release. The fulfilment of
requirements mentioned in this heading are confirmed based on the information
obtained during the establishment of manufacturing method at the development stage,
the control of manufacturing processes, or the tests for the release. Also even in the case
of absence of the heading “Manufacture” in monograph, it is important to note
appropriate controls of materials, manufacturing processes and intermediates in
individual drugs.
(3) The following regulations are newly added to Paragraph 34.
In principle, unless specified in the monograph, the JP Drugs are controlled
appropriately according to the direction under Residual Solvents of the general tests.
(4) The following regulations are newly added to Paragraph 35.
Concerning harmful substances reported as intentionally contaminated to drugs, the
control requirement for the presence or absence of contamination is described in the
heading “Potential adulteration” in the monograph, as necessary. These substances are
controlled by tests on materials, manufacturing processes, intermediates, or final
products. The necessity and frequency of the tests are specified separately on individual
drugs depending on the control strategy established as part of quality risk management.
(5) The following regulations are newly added to Paragraph 40.
Sterility means a condition when no target microorganism is detected by the specified
method. Sterilization means a process whereby killing or removal of all living
microorganisms in an object to be sterilized is accomplished. Aseptic technique is
controlled technique to maintain the aseptic condition.
(6) In Paragraph 48, among the parts which are not harmonized in the Japanese
Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia, the
“Exclusive recorded items only required by the Japanese Pharmacopoeia” are
◇ ◆
surrounded by the symbols “ ◇” instead of previous “ ◆”. What needs illustration is that,
◇
the application of “ ◇ ” in General Tests is planned to implement after the first
supplement of the Japanese Pharmacopoeia Seventeenth Edition.
(7) Other aspects of the text are improved.

3 General Rules for Crude Drugs are as follows.

(1) In Item 1, types of general rules for crude drugs and tests for crude drugs are added as
applicable to reflect the inclusion of new monographs for crude drugs.
(2) In Item 4, the origin of crude drugs serving as the acceptance criteria originally now
serves as the assessment criteria.
(3) In Item 5, under “Description” of crude drugs, value from microscopic examination
serving as the acceptance criteria originally now serves as the assessment criteria.

4 Major revisions of General Rules for Preparations are as follows.

 (1) “[2] General Notices for Packaging of Preparations” in which requirements for
packaging of preparations are recorded is added.
(2) Related texts about “Sterile Preparation”, “Final Sterilization” and “Aseptic
Manipulation” are added in [1] General Notices for Preparations (8).
(3) Related texts about containers and packaging of preparations in [1] General Notices for
Preparations (10) before revision are deleted.
(4) With the improvement of the items in General Notice 5, related texts about containers
and packaging in [2] Monographs for Preparations (1) and (2) before revision are
deleted.
(5) The definition of preparation in single-dose package in [1] General Rules for
Preparations (10) before revision is moved to [3] Monographs for Preparations (3).
(6) In 3.1 Injections (5)(ii) of [3] Monographs for Preparations, texts about non-aqueous
vehicles used as hydrophilic injections are added.
(7) Texts about other aspects are improved.

5 General Tests are as follows

(1) Test methods in Attached page 1 are newly included.
(2) Test methods in Attached page 2 are revised.
(3) With respect to standard substance, 23 varieties listed in Attached page 3 are newly
included, and name change is conducted for 9 varieties listed in Attached page 4.
Besides, 4 varieties listed in Attached page 5 are deleted.
(4) One standard solution used for volumetric analysis is newly added.
(5) Two standard solutions are newly added.
(6) With respect to test drug and solution, 157 are newly added, 33 are revised and 3 are
deleted.
(7) Twenty carriers/fillers used for chromatography are newly added.
(8) Four standard particles are deleted.
(8) Sterilization method and aseptic manipulation method are deleted.
(9) Descriptions about other aspects are improved.

6 Major revisions of Drug Monographs are as follows.

(1) Drug Monographs (hereinafter referred to as “newly included varieties”) newly included
in the Japanese Pharmacopoeia are shown in Attached page 6, and drugs included in the
Drug Monographs before revision but not included in new Pharmacopoeia (hereinafter
referred to as “deleted varieties”) are shown in Attached page 7.
(2) The revised Drug Monographs (hereinafter referred to as “revised varieties”) are shown
in Attached page 8.
(3) Drug Monographs with item of revised preparation homogeneity are shown in Attached
page 9.
(4) Drug Monographs whose alias is deleted are shown in Attached page 10.
(5) With the application of General Notice 34, Drug Monographs whose item of residual
solvents is deleted are shown in Attached page 11.

II. Reference information

1 The reference information is as follows, considering the notification of new Pharmacopoeia.
(1) Reference information listed in Attached page 12 is newly compiled.
(2) Reference information listed in Attached page 13 is revised.
(3) Reference information listed in Attached page 14 is abolished.
(4) Category classification of reference information is changed.

2 Reference information processing

Reference information refers to information about reference items required for ensuring drug
quality, and information about reference test methods of drugs listed in the Japanese
Pharmacopoeia, and it is not used for judgment of the suitability of pharmaceutical products
listed in the Japanese Pharmacopoeia.

III. Disposition of varieties contained in other sets of standards of drugs

1 Disposition of the Japanese Pharmaceutical Codex 2002

“For the items of standard substance and monograph in General Tests (1) listed in the
Attached page of The Japanese Pharmaceutical Codex 2002” (Notification No. 0920001 from
the Director of PFSB, MHLW, dated September 20, 2002), items listed in Attached page 15
are deleted.

2 Disposition of the Japanese Pharmaceutical Codex, Volume III

In the part of monograph stipulated in “About partial revision of the Japanese Pharmaceutical
Codex, Volume III” (Notification No. 1411 from the Director of PFSB, MHLW, dated
December 25, 2001), items listed in Attached page 16 are deleted.

3 Disposition of the Japanese Pharmaceutical Codex, Volume IV

In the part of monograph listed in Attached page of “About the compilation of the Japanese
Pharmaceutical Codex, Volume IV (About partial revision of the Japanese Pharmaceutical
Codex 1997)” (PMSB Notification No. 1117 of Secretary-General of PMSB, MHLW, dated
September 22, 1999), items listed in Attached page 17 are deleted.

4 Disposition of Japanese Pharmaceutical Excipients

In the part of monograph listed in Attached page of “About the Japanese Pharmaceutical
Excipients 1998” (PMSB Notification No. 178 of Secretary-General of PMSB, MHLW, dated
March 4, 1998), items listed in Attached page 18 are deleted.

IV. Others

1 Management of residual solvents, etc.

The application of General Tests “2.46 residual solvents” based on General Notice 34 in class
II solvent and class III solvent will be implemented after the first supplement of the Japanese
Pharmacopoeia Seventeenth Edition.
2 Standard substance
Twenty-three standard substances are added in the new Pharmacopoeia. Generally speaking,
the cooperation between production dealers and drug substance manufacturers is
indispensable in the production and distribution of standard substances. In consideration of
the content of the official standard of the Japanese Pharmacopoeia which is necessary for
ensuring drug quality of our country, we ask for your cooperation especially when providing
drug substances required by the production of standard substances (including latter batch
update).

3 Disposition of relevant notifications

“About the disposition of glycyrrhizic acid-contained drugs” (Notification No. 158 from the
Director of PAB, MHLW, dated February 13,1978) was abolished on April 1, 2016.

4 Transitional period
For the purpose of this revision, guidance on taking necessary measures for applications for
partial changes of approval items, etc. should be carried out until September 30, 2017.
Besides, the standards stipulated in the new Pharmacopoeia should be promptly implemented
to prevent contradiction with Paragraph 50 (Recorded items of immediate containers, etc.),
Paragraph 55 (Selling, granting forbidden, etc.) and Paragraph 56 (Sales, production
forbidden, etc.) of the law (Law No. 145,1960) for ensuring the quality, effectiveness and
safety of drugs and medical devices.