Translated by PhRMA Japan (Pharmaceutical Research and Manufacturers of America Japan) and
EFPIA Japan (European Federation of Pharmaceutical Industries and Associations Japan)
with consultation to MHLW (Ministry of Health, Labour and Welfare) and PMDA (Pharmaceuticals
and Medical Devices Agency).
This English version is intended to be a reference material to provide convenience for users. In theevent of inconsistency between the Japanese original and this English translation, the former shallprevail.

PSEHB/SD Notification No.0608-1
June 8, 2017

To: Director-general, Department of Health, Prefectural Governments

Director,
Safety Division,
Pharmaceutical Safety and Environmental Health Bureau,
Ministry of Health, Labour and Welfare(Official seal omitted)

Points to Consider for the Instructions for Package Inserts of Prescription Drugs

The above-mentioned matter has been notified through the “ Instructions for Package Inserts of
Prescription Drugs” (PSEHB Notification No.0608-1 dated June 8, 2017 from the Director-general of
the Pharmaceutical Safety and Environmental Health Bureau [PSEHB], Ministry of Health, Labourand Welfare [MHLW]) (hereinafter referred to as the “Director-General’s Notification”). Points toconsider for its operation are organized as presented in the Appendix. Please, therefore, make thisInstruction thoroughly known to all relevant industries and organizations under your supervision withattention being paid to the below-mentioned points, and also make the necessary arrangements forappropriate instructions to be given with regard to the package inserts for prescription drugs.
Please be advised that copies of this notification will be sent to the president of each separately listedorganization.

1.

Date of implementation
The date of implementation of this notification shall be the same as that of the Director-General’sNotification.
-1-

2.

Revision and repeal of existing notifications(1) Repeal
The “Instructions for Package Inserts of Prescription Drugs” (PAB/SD Notification No. 59
dated April 25, 1997 from the Safety Division [SD], Pharmaceutical Affairs Bureau [PAB],
Ministry of Health and Welfare [MHW]) (hereinafter referred to as the “Former Director’s
Notification”) will be repealed and replaced with the contents herein.
(2) Revision
With the repeal of the Former Director’s Notification “Instructions for Package Inserts of
Prescription Drugs’ (PAB/SD Notification No. 59 from the SD, PAB, MHW)” mentioned inAppendix 1 of the “Instructions for Package Inserts of Biological Products” (PMSB/SD
Notification No. 0520004 from the Director of the SD, Pharmaceutical and Medical Safety
Bureau [PMSB], [MHLW] dated May 20, 2003) will be amended to “‘Points to Consider for
Instructions for Package Inserts of Prescription Drugs’ (PSEHB/SD Notification No.0608-1
from the Director, SD, PSEHB, MHLW).”-2-

(Appendix)

Points to Consider for Instructions for Package Inserts of Prescription Drugs

I. General Points to Consider for Drafting
1.

Information in each section shall be written, in principle in an 8-point font so that the information
can be clearly and easily understood. If the font size is reduced because of spatial considerations,
it shall be at least a 6-point font. However, at least an 8-point font shall be used for the Sections
from “1. WARNINGS” to “15. OTHER PRECAUTIONS” except for the Section “3.
COMPOSITION AND PRODUCT DESCRIPTION” and information presented in tables andfootnotes.

2.

The format and specifications of the package inserts shall be, in principle, as follows using
Appendix 1 as a reference:(1) Specifications
A4 size paper
Generally up to four pages
A 1.7 cm left-hand margin shall be secured.
(2) Format
Drugs for which there are “1. WARNINGS”, the package inserts shall be printed on a white
sheet of paper with a red band on the corner of the upper right-hand side.
Other drugs: The package inserts shall be printed on a white sheet of paper.

3.

In principle, the package insert shall be written using a Ming-style font and two-byte characters
for Chinese characters, hiragana, and katakana, and one-byte characters for alphanumericcharacters. However, a Gothic font should be used for important descriptions such as a section
name to make them clearer than other descriptions. Red should not be used for letters, except for
sections otherwise specified.

4.

Unless otherwise specified, in general the heading shall use that which is indicated in the“Instruction for Package Inserts of Prescription Drugs (PSEB Notification No.0608-1 dated June
8, 2017 from the Director-General, PSEB, MHLW)” (hereinafter referred to as the“Director-General’s Notification”). However, the Japanese notation for “効能又は効果” in thesection title “4. INDICATIONS,” and “5. PRECAUTIONS CONCERNING INDICATIONS,”, aswell as that for “ 用 法 及 び 用 量 ”
ADMINISTRATION,”

and

“7.

likewise in the section “6. DOSAGE AND

PRECAUTIONSCONCERNINGDOSAGEAND

ADMINISTRATION” can be replaced with “効能効果” or “効能・効果”, and “用法用量” or “用法・用量”, respectively.

-3-

5.

The section numbers listed in the Director-General’s Notification shall be used. When lower-levelsections are established, sections down to the third level such as “1.1.1” may be formed. If section
numbers are needed further, parentheses such as “(1)” shall be utilized.

6.

When a related section is mentioned as a section that should be referred to, a section number shallbe used, and it shall be stated at the end of the text, for example, “see the Section 1.1.1.”

7.

When the data comparison with other drugs is described, in principle, the non-proprietary namesof comparator drugs shall be included. However, if the results of a bioequivalence study aredescribed, the brand names of the reference drug or reference biological drug shall be included.

8.

When the results of a bioequivalence study are described, they shall be included in the Section“16. PHARMACOKINETICS,” “17. CLINICAL STUDIES,” or “18. PHARMACOLOGY”
according to endpoints for equivalence.

II. Points to Consider for Each Section
A. Date of Preparation or Revision (year/month)(1) The dates of preparation or revision (year/month) followed by the version number inparentheses shall be included in the upper-left corner of the package inserts.
(2) Revisions shall be made in the following manner when items that will have a major effect on
the use of the drug are revised.
[1] The preparation date (year/month) or the revision date (year/month) shall be displayed fortwo consecutive revisions, and when a new revision date (year/month) is entered, therevision date (year/month) before the previous revision, shall be deleted (the preparation
date at the time of the second revision), and the new revision date (year/month) shall be
added to the previous revision date (year/month). In addition, it shall be made clear
whether the revisions are for the current revision or the previous revision.
[2] The part that is revised shall be marked by an asterisk (*) before the applicable section
number. In addition to clarifying the location of a revision, the corresponding revision date(year/month) and version number shall be indicated with the same symbol. When thelower-level sections are entirely revised, an asterisk “*” shall be attached to the one
upper-level section. In the second or subsequent revisions, revised information shall beidentified with “**” for the current revision and “*” for the previous revision.
[3] When a revision results from the release of reexamination or reevaluation results orchanges in the indications or dosage and administration, in the parentheses after the date ofrevision (year/month), “Reexamination Results” or “Reevaluation Results,” “Change in the
Indications,” “Change in the Dose,” or “Change in the Administration” shall be statedfollowing the version number.
B.

Standard Commodity Classification Number of Japan
Under the heading of the “Standard Commodity Classification Number of Japan”, the number
shall be clearly indicated, enclosed in a box on the upper-right side of the package inserts.

C.

Approval Number, Date of Initial Marketing in Japan
-4-

(1) Under the heading of the “Approval Number”, the number shall be clearly indicated, enclosed
in a box and entered below the “Standard Commodity Classification No. of Japan” as a rule.
(2) When indicating the date of initial marketing in Japan (year/month), the heading for the dateof initial marketing in Japan (year/month) shall be shortened to “Initial Marketing in Japan,”enclosed in a box and entered below the “Approval Number.”D. Storage, Shelf Life
Subsections shall be added for “Storage” and “Shelf Life” and presented below the “Date ofPreparation or Revision (year/month).”E.

Therapeutic Category(1) Consideration shall be paid to drugs that are classified into the same therapeutic category sothat their classification names are consistent.
(2) It is, in principle, unnecessary to provide the characteristics of the drug product. However, thisis not applicable to cases where it is necessary to differentiate drugs with different indications
or dosage and administration by the therapeutic category name for promoting their appropriate
use.

F.

Regulatory Classification(1) Drugs subject to the regulatory classification shall be those specified as follows: Poisonous
drugs and powerful drugs in Article 44, Paragraphs 1 and 2 of the Act on Securing Quality,
Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy
Products, Gene Therapy Products, and Cosmetics (Law No. 145 in 1960; hereinafter referred
to as the “PMD Act”); narcotics and psychotropic drugs in Article 2, Items 1 and 6 of the
Narcotics and Psychotropics Control Law (Law No. 14 in 1953); stimulants and stimulant raw
materials in Article 2, Paragraphs 1 and 5 of the Stimulants Control Law (Law No. 252 in
1945); habit-forming drugs in Article 50, Item 11 of the PMD Act; special approval drugs in
Article 14-3, Paragraph 1 of the PMD Act; and prescription drugs in Article 49, Paragraph 1 of
the PMD Act.
(2) The complete name that indicates the regulatory classification shall be entered above or on theleft-hand side of the brand name.
(3) For psychotropic drugs, subcategories of Class 1, 2, or 3 psychotropic drugs shall be includedin parentheses after “Regulatory Classification” in accordance with the Cabinet Order todesignate narcotics, raw material plants of narcotics, psychotropic drugs and raw materials of
narcotics and psychotropic drugs (Cabinet Order No. 238 in 1990).
(4) For habit-forming drugs, special approval drugs, or prescription drugs, notes for each piece of
information shall be provided as follows: For habit-forming drugs, “Caution - The drug may
form habits”; for special approval drugs, “Caution - Special approval drug”; and forprescription drugs, “Caution - Use it under a prescription of a physician, etc.”

G. Name of Product
The names shall be included in the following order:-5-(1) Non-proprietary name and then the standard name or the name stipulated in the JapanesePharmacopoeia (JP)(2) Brand name
1.

WARNINGS
Information shall be written in red, including the heading, and enclosed within a red box, using a
Gothic font.

2.

CONTRAINDICATIONS (This drug should not be administered to the following patients.)
Information including the heading shall be enclosed within a red box; however, the text shall not
be written in red.

3.

COMPOSITION AND PRODUCT DESCRIPTION(1) “3.1 Composition”[1] The information shall be described for each brand name in a table format and include thename of the active ingredient (s) (if the active ingredient has a non-proprietary name, thenthat non-proprietary name should be stated) and the quantity (if the active ingredient isunclear, then its physicochemical property and a summary of the manufacturing methodshould be stated) in a standard amount of the product (for dosage forms such as tablets,
which can be counted, a fixed number of units should be stated, and for other dosage
forms, a fixed weight or amount should be stated).
[2] For drug excipients, in principle, all ingredients, except for those listed in Appendix 2, shallbe described. They shall be listed in reference to the “Implementation of the ‘Voluntaryagreement on listing drug additives’” (PMSB/SD Notification No. 0409001 and
PMSB/CND Notification No. 0409001 dated April 9, 2002 jointly issued by the Directorsof SD and Compliance and Narcotics Division [CND], PMSB, MHLW).
(2) “3.2 Product Description”[1] The information shall be described for each brand name in a table format.
[2] Products that needs to be described as sterile include ophthalmic solutions ophthalmic
ointments, and individual products that are required to be sterile at approval.

4.

INDICATIONS(No points to consider)

5.

PRECAUTIONS CONCERNING INDICATIONSPrecautions for clarifying the scope of indications approved, such as tests and diagnostic criteria
necessary for patient selection, shall be included in this section.

6.

DOSAGE AND ADMINISTRATION
When it is necessary to separately describe dosage and administration according to indications,titration, and dosage form, etc., information shall be described in an easy-to-understand mannersuch as in table format.

7.

PRECAUTIONS CONCERNING DOSAGE AND ADMINISTRATION
When a drug requires adjustments within the range of increases and decreases as appropriate but-6-out of the scope of the usual dosage and administration, information shall be included in thissection.
8.

IMPORTANT PRECAUTIONS(No points to consider)

9.

PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS(1) Information in the Section “9.1 Patients with Complication or History of Diseases, etc.” shallbe described by adding an appropriate section, “9.1.1 Patients with XX,” according tocomplications, past history, family history, genetic predispositions, and other relevant factors.
(2) When describing information in the Section “9.2 Patients with Renal Impairment,” specificparameters such as creatinine clearance and estimated glomerular filtration rate (eGFR) shallbe used for the severity of renal impairment to the extent possible.
(3) When describing information in the Section “9.3 Patients with Hepatic Impairment,” specificparameters such as Child-Pugh classification shall be used for the severity of hepatic
impairment to the extent possible.
(4) When stating that “this drug should not be administered” and “women should be instructed to
avoid breastfeeding” as precautions related to the Sections “9.5 Pregnant Women” and “9.6Breast-feeding Women,” they shall be described while fully considering clinical effects suchas exposure to fetuses or lactating babies (particularly for a topical formulation), clinical use
experience, and the availability of alternative drugs.
(5) When providing information in the Section “9.7 Pediatric Use,” the approximate age range of
newborns, babies, infants, or children means as mentioned below. However, if the specific age
is clear, “less than X years old,” “X years old or older, less than X years old” shall be also
indicated. It is also acceptable to use age categories other than:[1] Newborns are aged less than 4 weeks.
[2] Babies are aged 4 weeks to less than 1 year.
[3] Infants are aged 1 to less than 7 years.
[4] Children are aged 7 to less than 15 years.
(6) When describing information in the Section “9.8 Geriatric Use,” the approximate age of theelderly shall be defined as 65 years or older, and as necessary, information on the age group of
75 years or older shall be also included. However, if the specific age is clear, “X years old orolder” shall be also indicated. It is also acceptable to use age groups other than this.
(7) When describing information in the Sections “9.2 Patients with Renal Impairment,” “9.3Patients with Hepatic Impairment,” and “9.7 Pediatric Use,” if risks are assumed but there areno sufficient data on them because the applicable patients were excluded from clinical studies,such a fact shall be stated.
(8) When describing information in the Sections “9.5 Pregnant Women” and “9.6 Breast-feeding
Women,” if data from clinical use experience, epidemiological surveys, or other relevant
sources are clinically beneficial, they shall be provided as information on appropriate use.

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10. INTERACTIONS(1) Information shall be presented in a manner that makes it as easily understandable as possible
such as in table format. Precautions for co-administration can be provided in a descriptive
manner depending on cases.
(2) The Section “10. Contraindications for Co-administration (This drug should not be
co-administered with the following drugs.)” shall be entered into a table with a red frame, but
the text shall not be written in red.
(3) When indicating the names of drugs, names of bio-similar products shall be represented by the
non-proprietary name of the reference biological product as “XXXX product”
11. ADVERSE REACTIONS(1) For the frequency of adverse reactions, in principle, the incidence shall be indicated as apercentage to one decimal place, and if the incidence is less than 0.1%, such a fact shall be
stated on the basis of the results of pooled clinical studies to investigate efficacy and safety ofthe drug within the scope of approved indications and dosage and administration.
(2) In cases of adverse reactions were accumulated from spontaneous reports and Post-marketing
Surveillance, etc. and the frequency is unknown, “frequency unknown” shall be added.
However, when clinical study data are quite limited for orphan drugs for example, and only
when it is particularly useful to present the frequency of adverse reactions based on
Post-marketing Surveillance, etc., the frequency shall be indicated by specifying the sources ofreferences.
(3) When adding the frequency of adverse reactions for generic drugs and bio-similar products, if
there are results from clinical studies that were accurately and objectively conducted using thegeneric drugs or bio-similar products themselves, the frequency shall be described on the basisof the said results. When the frequency for the concerned generic drugs or bio-similar products
is unknown, in principle, the frequency of the reference drug or reference biological productshall be included.
(4) When clinically significant adverse reactions are known for similar drugs and the samecaution may be necessary for the drug concerned, they shall be presented in the same manneras those that are known for the concerned drug without mentioning “similar drugs.”(5) Information in the Section “11.2 Other Adverse Reactions” shall be provided in table format.
(6) Precautions for infections associated with drugs shall be presented as specified for adverse
reactions.
12. INFLUENCE ON LABORATORY TESTSWhen the use of the drug causes apparent changes in laboratory data, conditions, effects, reasons,and other relevant matters associated with such changes shall be briefly described.
13. OVERDOSAGE
It shall not be necessary to present information in this section if there is no case of an intoxication
symptom or a typical intoxication symptom is unknown.

-8-14. PRECAUTIONS CONCERNING USE(1) “Precautions concerning the preparation of the drug” shall include precautions when preparing
the drug. The use of protectors (such as eyeglasses, gloves, and a mask) by persons preparing
the drug for avoiding exposure shall be included in this section.
(2) “Precautions concerning administration of the drug” shall include precautions for the route ofadministration, dosage form, injection rate, site of administration, and other relevant matters.
(3) “Precautions concerning the dispensing of the drug” shall provide instructions to patients.
Precautions for the storage of the drug by patients shall be included in this section.
(4) When there are precautions when making a diagnosis for diagnostics, they shall be presented
by adding a section “Precautions for diagnosis.”
15. OTHER PRECAUTIONS(1) When providing information in the Section “15.1 Information Based on Clinical Use,” even if
evaluation has not been established on data such as carcinogenicity and mortality, it shall be
stated as objectively as possible preceded by a phrase that “it has been reported that…” on thebasis of epidemiological studies, etc.
(2) Information in the Section “15.2 Information Based on Nonclinical Studies” shall be described
while considering the safety margin as compared with clinical exposure.
16. PHARMACOKINETICS(1) The pharmacokinetics shall be separated into those of healthy individuals and those ofpatients, and if necessary, a description of the condition of the patients shall be added. Whendata are from non-Japanese populations, such a fact shall be stated.
(2) When providing the results of a population analysis or simulation, such a fact shall be stated
and they shall be differentiated from actual results.
(3) If the studied dosage and administration are different from those approved, such a fact shall bealso mentioned as a note.
17. CLINICAL STUDIES(1) “17.1 Clinical Studies for Efficacy and Safety”[1] Information shall be described by adding an appropriate section so that the positioning ofstudies (e.g., the phase of development and study design) can be understood.
[2] When the results from a global study or data from a non-Japanese population are provided,such a fact shall be clearly stated. For a global study, the number of Japanese subjects shallalso be included.
[3] Safety results shall be described on the basis of adverse reactions or adverse events.
However, it shall be specified whether the results are based on adverse reactions or adverse
events.
(2) “17.3 Others”
If results using dosage and administration that are different from those approved are describedsuch a fact shall also be mentioned as a note.

-9-18. PHARMACOLOGY(1) For a combination drug, when explaining the pharmacological action of each active ingredient,
expressions that give the impression that the drug can be used for indications other than theapproved indications (or, in drugs exempt from approval, for indications outside therecognized medical and pharmaceutical range) shall not be used. For a combination drug,
synergistic effects shall be included only when sufficiently objective data are available.
(2) For diagnostics, the Section “18.1 Mechanism of Action” shall be replaced with “18.1Measurement Method,” and measurement principles supporting approved indications shall be
described.
19. PHYSICOCHEMICAL PROPERTIES
A non-proprietary name shall be mentioned in Japanese followed by its English name inparentheses.
20. PRECAUTIONS FOR HANDLINGIn addition to precautions for handling that are stipulated in the JP or the standards pursuant to theprovisions of Article 42, Paragraph 12 of the PMD Act, regulations for drug management such as
avoiding fire shall be described, if any.
21. APPROVAL CONDITIONS(No points to consider)
22. PACKAGING(1) The packaging form such as an ampule, vial, syringe, bottle, or bag shall be included. The
materials or characteristics of the container shall be, as necessary, described. If a desiccant iscontained in the package, such a fact shall be stated.
(2) The packaging unit such as the number of products, weight, and volume per unit according to
the packaging form shall be included. If the product is individually packed, such a fact shall be
stated. For sheet packaging, the number of products per sheet and the number of sheets shallbe clearly indicated.
(3) When describing information on tools and instruments, the number of gauges shall also bementioned for an injection needle. When describing information on a solution, the volume andother information shall be indicated together.
23. REFERENCES(1) Parts quoted from the references shall have the reference number attached so that the reader
can locate the reference.
(2) The Vancouver style (the name of the author (s), name of the journal, year of publication,
volume number, and the first to last pages) shall be used for listing references.
(3) If in-house documents are cited, the details of the documents shall be described clearly and asconcretely as possible to facilitate users’ requests for literature. If a summary of approval
application documents is published, the date of the corresponding approval and document
number shall also be indicated.

- 10 -

(4) For generic drugs and bio-similar products, the same published literature as that for theirreference drugs and reference biological products shall be listed, as a rule. However, this is notapplicable to the case where it is necessary to provide different information according to
product differences.
24. REFERENCE REQUEST AND CONTACT INFORMATION(No points to consider)
25. PRECAUTION CONCERNING HEALTH INSURANCE BENEFITS(No points to consider)
26. MARKETING AUTHORIZATION HOLDER, etc.
(1) If the names of the distributor, licenser company, etc. are indicated, they shall be mentioned
after the marketing authorization holder.
(2) For foreign special approval drugs, in addition to the name and address of the appointed
marketing authorization holder, the name of the foreign special approval holder and thecountry where it is residing shall be provided.

- 11 -

(Appendix 1)

Standard Commodity
Classification Number ofJapan*Revised: Month 20XX (XXth version, XX)
Storage:
Therapeutic Category
Expiration date:

Regulatory Classification● mg

Non-proprietary Name, Standard Name, or Name
Specified in the Japanese Pharmacopoeia

Prescription drugNote)▲ mg

Approval Number
Initial Marketing inMonth 20XX Month 20XX
Japan

Brand Name
Name of ProductNote) Caution - Use only pursuant to the prescription of a physician, etc.

1. WARNINGS

10. INTERACTIONS
10.1 Contraindications for Co-administration (This drug
should not be co-administered with the following drugs.)
Drugs

2. CONTRAINDICATIONS (This drug should not be
administered to the following patients.)

Signs, symptoms, andmeasures

Mechanism and risk
factors10.2 Precautions for Co-administration (This drug should be
co-administered with caution.)
3. COMPOSITION AND PRODUCT DESCRIPTION
3.1 Composition<Table format>
3.2 Product Description<Table format>
4. INDICATIONS

Drugs

Signs, symptoms, andmeasures

Mechanism and risk
factors

5. PRECAUTIONS CONCERNING INDICATIONS

11. ADVERSE REACTIONS
11.1 Clinically Significant Adverse Reactions
11.1.1 XX

6. DOSAGE AND ADMINISTRATION

11.2 Other Adverse Reactions≥X%

7. PRECAUTIONS CONCERNING DOSAGE AND
ADMINISTRATION

0.1 to <X% <0.1%

8. IMPORTANT PRECAUTIONS
9. PRECAUTIONS CONCERNING PATIENTS WITH
SPECIFIC BACKGROUNDS
9.1 Patients with Complication or History of Diseases, etc.
9.2 Patients with Renal Impairment
9.3 Patients with Hepatic Impairment
9.4 Persons with Reproductive Potential
9.5 Pregnant Women
9.6 Breast-feeding Women
9.7 Pediatric Use
9.8 Geriatric Use

12. INFLUENCE ON LABORATORY TESTS
13. OVERDOSAGE
14. PRECAUTIONS CONCERNING USE
15. OTHER PRECAUTIONS
15.1 Information Based on Clinical Use
15.2 Information Based on Nonclinical Studies
16. PHARMACOKINETICS
16.1 Blood Level
16.2 Absorption
16.3 Distribution
16.4 Metabolism
16.5 Excretion- 12 -

Frequency
unknown

16.6 Patients with Specific Backgrounds
16.7 Drug Interactions
16.8 Others
17. CLINICAL STUDIES
17.1 Clinical Studies for Efficacy and Safety
17.2 Post-marketing Surveillance, etc.
17.3 Others
18. PHARMACOLOGY
18.1 Mechanism of Action
18.2 XX Effect
19. PHYSICOCHEMICAL PROPERTIES
20. PRECAUTIONS FOR HANDLING
21. APPROVAL CONDITIONS
22. PACKAGING
23. REFERENCES
24. REFERENCE REQUEST AND CONTACTINFORMATION
25. PRECAUTION CONCERNING HEALTH INSURANCEBENEFITS
26. MARKETING AUTHORIZATION HOLDER, etc.

13

(Appendix 2)
Drug type
Injections (including body fluids, artificial
perfusion agents and powders for injection)

drug excipients
1. Calcium chloride
2. Potassium chloride
3. Sodium chloride
4. Hydrochloric acid
5. Citric acid
6. Sodium citrate
7. Succinic acid8. Acetic acid (Note 1)
9. Potassium acetate
10. Sodium acetate
11. Tartaric acid12. Potassium hydroxide
13. Sodium hydroxide
14. Water for injection
15. Physiological saline
16. Sodium carbonate
17. Sodium bicarbonate
18. Lactic acid
19. Sodium lactate
20. Maleic acid
21. Sulfuric acid
22. Phosphoric acid
23. Potassium phosphate
24. Dibasic sodium phosphate
25. Potassium hydrogenphosphate
26. Dibasic calcium phosphate
27. Potassium dihydrogenphosphate
28. Dibasic sodium phosphate
29. Disodium hydrogenphosphate
External agents used for mucous membrane
1. Calcium chloride(ophthalmic instillations, ophthalmic ointments, 2. Potassium chloride
eyewashes, nasal sprays, ear drops,
3. Sodium chloride
suppositories [for the anus, vagina, or urethra], 4. Hydrochloric acidintra-anal injections, inhalants, buccal agents
5. Citric acid[sublingual tablets], troches, oral cavity patches, 6. Sodium citrateoral cavity applications, gargles, and mucosally
7. Succinic aciddelivered dental drugs)
8. Acetic acid (Note 1)
9. Potassium acetate
10. Sodium acetate
11. Tartaric acid12. Potassium hydroxide
13. Sodium hydroxide
14. Purified water (Note 2)
15. Physiological saline
16. Sodium carbonate
17. Sodium bicarbonate
18. Lactic acid
19. Sodium lactate
20. Maleic acid
21. Sulfuric acid14

22. Phosphoric acid
23. Potassium phosphate
24. Dibasic sodium phosphate
25. Potassium hydrogenphosphate
26. Dibasic calcium phosphate
27. Potassium dihydrogenphosphate
28. Dibasic sodium phosphate
29. Disodium hydrogenphosphate
Note 1: Including glacial acetic acid and acetic acid anhydride
Note 2: Including water for injection and sterile purified water

15

(Appended list)
Japan Medical Association
Japan Dental Association
Japan Pharmaceutical Association
Japanese Society of Hospital Pharmacists
Federation of the Pharmaceutical Manufacturers’ Association of Japan
Japan Pharmaceutical Manufacturers Association
Japan-Based Executive Committee, Pharmaceutical Research and Manufacturers of America
European Federation of Pharmaceutical Industries and Associations
Japan Generic Medicines Association
Japan Kampo Medicines Manufacturers Association
Japan Medicinal Plant Federation
Japan CRO Association
Office of Safety I of the Pharmaceuticals and Medical Devices Agency
Office of Safety II of the Pharmaceuticals and Medical Devices Agency

16Version:
1.0 (23-January-2018)
Reference:
Points to Consider for the Instructions for Package Inserts of Prescription Drugs
http://www.pmda.go.jp/files/000218448.pdf(Japanese original text)17