Japanese Journal of Generic Medicines ─ Rules for Contributions
June 2024

1. Qualification of Contributors
As a rule, the principal author of a paper shall be a member of
the Japanese Society of Generic and Biosimilar Medicines. However,this does not apply if someone outside Japan submits a paper or if apaper is submitted on request.

2. Copyrights
The copyrights of papers, abstracts, articles and the like thatare published in the journal are vested in the Japanese Society ofGeneric and Biosimilar Medicines.

3. Details of Papers
Papers to be submitted shall discuss the formulation, quality,
equivalence, added value and other scientific reporting on genericmedicines (including biosimilars; GE); surveillance and research
relating to the provision of information and dependable supply; andresearch, surveillance, interpretation and reporting on pharmacology and medical economics of GE. The papers shall never have been
published or submitted to any scientific journal or other publisher.
Any research into humans or human tissues shall comply with theethical principles of the World Medical Association Declaration of
Helsinki. Such research must have the approval of the ethics committee of the institution or equivalent body, depending on the subject area. Any animal testing shall follow the animal test guidelines
prescribed by the institution.
3-1 Examples of Subject Areas
Formulation design/stability testing of GE
Bioequivalence testing of GE
Efficacy/safety of GE
Added value of GE
Industrialization of GE
Manufacture/quality control of GE
Assessment of GE at medical institutionsR eporting on discussions by manufacturers based on assessments
by medical institutions
Requests for GE from medical institutions
Various issues associated with the introduction of GE into hospitalsC urrent status of the use of GE at hospitals and associated problems
Supply/distribution of GE and provision of information
The relationship between domestic and international pharmaceutical regulations/guidelines, and the development/manufacture ofGE
GE and medical economics
Etc.
3-2 Type
Japanese Journal of Generic Medicines mainly accepts general
papers, short reports, research results and review articles as a rule.
–	General papers: as a rule, they need to include new findings on
GE obtained from original research activities.
– 	Short reports: they shall include new findings, valuable data,case reporting and others as a rule, even if it is fragmentaryresearch.
– 	Research results: they shall include valuable data, although it is
not necessary to include new findings.
– 	Review articles:82	Comprehensive papers: these should be based on the author’s
research performance and include an overview and comments
on studies associated with the author’s field.	Invited papers: these are written at the request of the editorial
board of the journal.
– 	Lecture reports: these are written at the request of the editorial
board of the journal by the presenters of lectures (symposiums,etc.) at the meeting of the Japanese Society of Generic andBiosimilar Medicines. However, submissions based on shortpresentations are handled as general papers.
3-3 Languages
Japanese or English
3-4 Length
The length of manuscripts, according to the type of the manuscript, should be as follows. Character count does not include thetitle, the name(s) of the author(s), the institution(s) of the author(s),as stated in 3-5, and the summar y in English (with its Japanesetranslation) and keywords, and include the main text, figures andtables, references and footnotes.
– 	General papers: the printed paper shall not exceed 7 pages(1,900 Japanese characters by 6 = 11,400 Japanese characters).
– 	Short reports: the printed paper shall not exceed 5 pages (1,900Japanese characters by 4 = 7,600 Japanese characters).
–	Research results: the printed paper shall not exceed 7 pages(1,900 Japanese characters by 6 = 11,400 Japanese characters).
– 	Review articles:	Comprehensive papers: the printed paper shall not exceed 10pages (1,900 Japanese characters by 9 = 17,100 Japanese characters).	Invited papers: the printed paper shall not exceed 13 pages(1,900 Japanese characters by 12 = 22,800 Japanese characters).
–	Lecture reports:	Lectures of up to 30 minutes: the printed paper shall not exceed
5 pages (1,900 Japanese characters by 4 = 7600 Japanese characters).	Lectures of up to 60 minutes: the printed paper shall not exceed
10 pages (1,900 Japanese characters by 9 = 17100 Japanese characters).
– 	Each page should be A4 size, with 40 characters by 40 horizontal lines.
– 	A figure or a table corresponds to 300-600 Japanese charactersdepending on its size.
3-5 Format– 	The first page of the manuscript shall state the title, the namesof each author (if the paper is in Japanese, the names in Roman
alphabet are to be given as well), the name and address ofeach institution (the address is only required for the principleauthor), contact e-mail address, the contact for requesting copies and the contact address for proofreading.
– The second page shall contain an English summary of up to250 words (with its Japanese translation) and up to 5 keywords(with their Japanese translations).
– The main text should start from the third page.
–F igures, tables and photographs shall be labeled as Fig., Table,and Photo respectively. Serial numbers are to be given if there
is more than one. They should carry their own titles and besupplied separately from the main text. In principle, the originalfigures, tables, and photographs prepared by the author should

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be provided. Citation of figures, tables and photographs shall beindicated in the text or in the margin.
–U nits: International System of Units (SI) should be used basedon the Japanese Pharmacopoeia, 16th edition (2011).
–R eferences: References are numbered in the order in which they
are cited, and the number of each reference is given followed bya closing parenthesis as a superscript to the relevant part, alongwith a closing parenthesis. All references are summarized in thereferences section at the end of the paper.
–D escription of referencesF or journals, give the details in the following order: 1) name ofthe author (names of a maximum of 3 authors should be given;
other names have to be omitted), 2) title of the paper, 3) nameof the journal, 4) year of publication, 5) volume number and6) page numbers. The name of the journal with its title in theRoman alphabet is typed in italics.	For published books, give the details in the following order: 1)
name of the author, 2) title of the book (and the section title),3) edition and volume number, 4) name of the editor, 5) placeof publication, 6) name of the publisher, 7) year of publication
and 8) page number. The accessed date should also be given forweb pages.
ExampleJournal articles:1)	Haskins LS, Tomaszewski KJ, Crawford P. Patient andphysician reactions to generic antiepileptic substitution
in the treatment of epilepsy. Epilepsy Behav., 2005 ; 7 :98-105.
2)	Grant R, O’Leary K, Weilburg J, et al. Impact of concurrent medication use on statin adherence and refill persistence. Arch Intern Med., 2004 ; 164 : 2343-8.
Books:3) Meltzer PS, Kallioniemi A, Trent JM. Chromosome
alterations in human solid tumors. In: Vogelstein B,Kinzler KW, editors. The genetic basis of human cancer.
New York：McGraw-Hill；2002. p. 93-113.
–F ootnotes	A footnote shall be provided on the same page as the one inwhich the footnote symbol or number is placed. The footnotesymbol or number shall be clearly indicated in the text.
– Disclosure of Conflict of Interests (COI)	In accordance with this Society’s Rules on Managing Conflict ofInterests, all papers submitted shall carry a declaration at the endof the main text, stating whether or not any of the coauthors has
a conflict of interests. If there is a conflict of interests, the nameof the company or organization in question shall be stated. If any
financial assistance, whether direct or indirect, was received froma specific company in the process of conducting the research orpreparing the manuscript, this fact shall be stated in the paper.	Example: No conflict of interests.		Conflict of interests. This study was funded by ○○Co., Ltd.

Tokyo, 162-0801, Japan		
TEL: +81-3-6824-9363 FAX: +81-3-5206-5332		
E-mail: jjgm-edit@bunken.co.jp		Contact: Editorial Office of the Japanese Journal ofGeneric Medicines–	T he acceptance procedure shall be deemed complete when
the contributor receives an e-mail response from the contact.
If no such e-mail arrives within one or two business days, thecontributor shall make an inquiry to the contact as to whether
to re-send the contribution data as there could be cases wherecontribution data fail to be properly received.

5. Evaluation of the Papers and Results
Papers submitted are subject to an assessment for acceptanceby two examiners. If a paper is returned after assessment with arequest to be resubmitted, it shall be sent back within two monthsof the day the paper is returned. If the paper is resubmitted after
this time, it shall be handled as a new contribution. The journal
may request partial corrections to a manuscript for publication. Theorder in which papers are published shall in principle be the orderin which they are received, although it is subject to change for theconvenience of assessment and editing.
However, review articles (invited papers) and lecture reports
defined in 3-2 are not subject to the assessment mentioned above,
but shall be accepted for publication or rejected based on the judgment of the chair of the editorial board; however, the journal may
request partial corrections of a manuscript for publication.

6. Publication Fees
Contributors (except the author of an invited paper or a lecturereport) shall pay upon request the following publication fees (consumption tax not included) after the paper has been accepted.
– 	2,000 yen per printed page– 	3,000 yen per page exceeding the length provided in 3-4– 	Figures and tables preparation fee if they are prepared separately: 2,000 yen per 50 cm2

7. Separate Off-Prints
The journal provides PDF file of relevant page to the author at thetime of publication.
If the author wishes to obtain printed separate off-prints, the number of copies to be needed can be ordered at the time of proofreading, which is available for a fee.

8. Others– 	The author may proofread a paper only once. As a rule, noadditions or corrections shall be accepted thereafter, except for
typographical errors.
– 	These rules shall apply from the papers published in the journal, volume 18, number 2. Contributors should refer to thecurrent rules for contributions (available on the web site of theJapanese Society of Generic and Biosimilar Medicines).

4. Contribution Procedure
A contributor shall send the contribution data to the following
address by E-mail. Microsoft Office software shall be used for preparing the documents:– Address: 	Editorial Office of the Japanese Journal of GenericMedicines		c/o International Academic Publishing Co., Ltd.		Publishing Center, 332-6, Yamabuki-cho, Shinjuku-ku,

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Appended table: Instruction by submission type
Type

LengthEvaluation

Publication fee

General papers

The printed paper shall not
exceed 7 pages

Subject to assessment

2,000yen ×
number of pages

Short reports

The printed paper shall not
exceed 5 pages

Subject to assessment

2,000yen ×
number of pages

Research results

The printed paper shall not
exceed 7 pages

Subject to assessment

2,000yen ×
number of pages

Review articles:
Comprehensivepapers

The printed paper shall not
exceed 10 pages

Subject to assessment

2,000yen ×
number of pages

Review articles:
Invited papers

The printed paper shall not
exceed 13 pages

Not subject toassessment: partial
corrections may berequested by thejudgment of the chairof the editorial board.

Free

Lecture reports

Lectures of up to 30 minutes:
the printed paper shall not
exceed 5 pages
Lectures of up to 60 minutes:
the printed paper shall not
exceed 10 pages

Not subject toassessment: partial
corrections may berequested by thejudgment of the chairof the editorial board.

FreeNotes

Submissions
based on shortpresentations
are handled asgeneral papers.

Recommendations concerning statistical analysis, etc.
The editorial board of the Japanese Journal of Generic Medicines

Samples
When study samples are drugs used for medical purposes, givethe name of the manufacturer and the lot numbers if possible. If
symbols such as “A,” “B,” etc. are used, provide the reason.
Statistics
For comparison between 2 or more groups, it is recommended
to prepare the paper taking the following matters concerning data
aggregation, statistical analysis, and discussion into consideration:1)	The parameter that shows the fluctuation of measured values
should basically not be given in standard error, but in standard
deviation. It is desirable to show the data distribution visuallysuch as by a Box plot.
2)	For comparison of the mean between groups,2-a)	Discuss the uniformity of the arrangement of backgroundfactors (items) other than the evaluation item between thegroups to be compared.

842-b)	Describe the authors’ opinion on how large a difference inthe value of the subject indicator has to be considered as ameaningful difference (clinically significant differences).
2-c)	Describe the justification for the selection of the number ofsubjects and the number of cases in the study.
2-d)	Use multiple comparison to compare 3 or more groups.
2-e)	The p value should not be shown as p<0.05 or p<0.01, etc;
the precise p value should be shown.
2-f)	For the discussion of results based on statistical tests andstatistical estimations, clinically significant differences, thenumber of data (number of subjects and number of cases),etc. should be considered in addition to the results such asstatistical significance tests. Note that the statistical conclusion is not directly connected to clinical “equivalence” or“nonequivalence.” It may help to include and utilize a confidence interval so that a hasty discussion can be avoided.
Please take the recommendations listed above into consideration.

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