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Journal of Generic Medicines
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Journal of Generic Medicines

The Business Journal for the Generic Medicines Sector

Editor
Brian Tempest Hale & Tempest Co Ltd., UK


eISSN: 17417090 | ISSN: 17411343 | Current volume: 13 | Current issue: 3 Frequency: Quarterly

Journal of Generic Medicines is the major, peer-reviewed, international business journal written by and for professionals working in the generic medicines sector. It includes expert analysis, briefings and legal updates on all aspects of business development, regulatory affairs, manufacturing and marketing affecting the generic pharmaceutical industry. Each quarterly issue publishes papers which are of direct relevance to practitioners and that meet the highest intellectual standards.

This journal is a member of the Committee on Publication Ethics (COPE).

 

Under the guidance of a highly respected Editor and an expert Editorial Board each quarterly issue publishes peer-reviewed analyses, briefings and updates which are of direct relevance to practitioners and that meet the highest intellectual standards.

Subscribing to Journal of Generic Medicines will give you and your organization access to the latest thinking from some of the world's leading authorities, including articles on:

  • strategies for challenging and protecting patents
  • pricing and reimbursement trends and policies - country by country
  • fair and unfair tactics to block generic competition
  • patent expiries and their impact on national, regional and global markets
  • business development strategies and licensing agreements
  • clinical trials and bioequivalence studies
  • m&a strategy
  • regulatory affairs
  • major buyers' tender procedures
  • data exclusivity and patents
  • manufacturing and outsourcing
  • briefings from government agencies
  • marketing and branding strategies
  • strategies for challenging innovators
  • analysis of disease sectors
  • own brand markets
  • R&D
  • legal briefings - including case law discussions
  • market reviews
  • the OTC generic market
  • packaging and labelling
  • biogenerics
  • purchase strategies

Consulting Editor
Greg Perry European Generic Medicines Association, Belgium
Editorial Board
Ranjit Barshikar Quality by Design / cGMP, India
Nicholas Cappuccino Pharmaceutical Intellectual Resource Services LLC, USA
Carlos M. Correa University of Buenos Aires, Argentina
Dolores Cullen MFJ International, USA
Marcel Daniels Teva Pharmaceutical Industries Ltd, Belgium
Richard L. DiCicco Technology Catalysts International, USA
Eric B. Fastiff Lieff Cabraser Heimann & Bernstein, USA
Thomas Faunce Australian National University, Australia
Gordon Johnston Generic Pharmaceutical Association, USA
Fabiana Jorge MFJ International, USA
Yahudah Livneh VP Corporate IP & Legislative Affairs, Israel
Kate Lynch Generic Medicines Industry Association Pty Ltd, Austrialia, Australia
Richard Milchior Granrut Avocats, France
Sandeep Rathod Matrix Laboratories Limited, India
Frederick H. Rein Goodwin Procter LLP, USA
Juichi Riku Sawai Pharmaceutical. Co. Ltd., Japan
Paolo Romangnoli Pharmaceutical Chemicals, Italy
Sol Ruiz Spanish Medicines Agency (AEMPS), Spain
Enrique Seoane-Vasquez Massachusetts College of Pharmacy and Health Sciences, USA
Steven Simoens Catholic University of Leuven, Belgium
Lawrence Yu University of Michigan, USA
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  • EBSCOhost: Current Abstracts
  • EMBASE/Excerpta Medica
  • Gale: Academic OneFile
  • Gale: Diversity Studies Collection
  • Gale: Expanded Academic ASAP
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  • Gale: Student Resource Center College
  • ProQuest Central
  • ProQuest Family Health
  • ProQuest Health & Medical Complete
  • Reactions Weekly
  • Scopus
  • Manuscript Submission Guidelines: Journal of Generic Medicines

    This Journal is a member of the Committee on Publication Ethics.

    This Journal recommends that authors follow the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals formulated by the International Committee of Medical Journal Editors (ICMJE).

    Please read the guidelines below then visit the Journal’s submission site http://mc.manuscriptcentral.com/jgm to upload your manuscript. Please note that manuscripts not conforming to these guidelines may be returned.

    Only manuscripts of sufficient quality that meet the aims and scope of Journal of Generic Medicines will be reviewed.

    There are no fees payable to submit or publish in this journal.

    As part of the submission process you will be required to warrant that you are submitting your original work, that you have the rights in the work, that you are submitting the work for first publication in the Journal and that it is not being considered for publication elsewhere and has not already been published elsewhere, and that you have obtained and can supply all necessary permissions for the reproduction of any copyright works not owned by you.

    1. What do we publish?
      1.1 Aims & Scope
      1.2 Article types
      1.3 Writing your paper
    2. Editorial policies
      2.1 Peer review policy
      2.2 Authorship
      2.3 Acknowledgements
      2.4 Funding
      2.5 Declaration of conflicting interests
      2.6 Research ethics and patient consent
      2.7 Clinical trials
      2.8 Reporting guidelines
      2.9 Data
    3. Publishing policies
      3.1 Publication ethics
      3.2 Contributor's publishing agreement
      3.3 Open access and author archiving
    4. Preparing your manuscript
      4.1 Formatting
      4.2 Artwork, figures and other graphics
      4.3 Supplementary material
      4.4 Reference style
      4.5 English language editing services
    5. Submitting your manuscript
      5.1 ORCID
      5.2 Information required for completing your submission
      5.3 Permissions
    6. On acceptance and publication
      6.1 SAGE Production
      6.2 Online First publication
      6.3 Access to your published article
      6.4 Promoting your article
    7. Further information

    1. What do we publish?

    1.1 Aims & Scope

    Before submitting your manuscript to Journal of Generic Medicines, please ensure you have read the Aims & Scope.

    1.2 Article Types

    Journal of Generic Medicines particularly welcomes contributions from professionals concerned with generic medicines, including case studies; new approaches; market reviews; regulatory and legal updates; empirical research; and other material of relevance to the generic pharmaceutical industry. They can be more descriptive (and less analytical) of current business practice, and need not display in-depth knowledge of previous academic work in the field. The Journal will also publish traditionally-styled academic papers which will be expected, at a minimum, to display a sound knowledge of previous work in the area and some original research content. All papers must have clear implications for business practice.

    An abstract should be included, comprising approximately 200 words. You should also list approximately six key words are also required. Papers should be in excess of 2,500 words and ideally in excess of 4,000 (but shorter papers will be considered). Submissions should be typewritten, double-spaced, on A4 or US letter paper.

    Authors are welcome to contact the editor if they wish to discuss their paper before submission. Please send inquiries to the Editor, Brian Tempest at brian.tempest@clara.co.uk.

    1.3 Writing your paper

    The SAGE Author Gateway has some general advice and on how to get published, plus links to further resources.

    1.3.1 Make your article discoverable

    When writing up your paper, think about how you can make it discoverable. The title, keywords and abstract are key to ensuring readers find your article through search engines such as Google. For information and guidance on how best to title your article, write your abstract and select your keywords, have a look at this page on the Gateway: How to Help Readers Find Your Article Online.

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    2. Editorial policies

    2.1 Peer review policy

    Journal of Generic Medicines operates a double-blind reviewing policy in which the reviewer’s and author’s names are mutually concealed.

    All manuscripts accepted for publication are subject to editing for presentation, style and grammar. Any major redrafting is agreed with the author but the Editor's decision on the text is final. Referees will be encouraged to provide substantive, constructive reviews that provide suggestions for improving the work and distinguish between mandatory and non-mandatory recommendations.

    As part of the submission process you may be asked to provide the names of peers who could be called upon to review your manuscript. Recommended reviewers should be experts in their fields and should be able to provide an objective assessment of the manuscript. Please be aware of any conflicts of interest when recommending reviewers. Examples of conflicts of interest include (but are not limited to) the below:

      • The reviewer should have no prior knowledge of your submission
      • The reviewer should not have recently collaborated with any of the authors
      • Reviewer nominees from the same institution as any of the authors are not permitted

    Please note that the Editors are not obliged to invite any recommended/opposed reviewers to assess your manuscript.

    2.2 Authorship

    Papers should only be submitted for consideration once consent is given by all contributing authors. Those submitting papers should carefully check that all those whose work contributed to the paper are acknowledged as contributing authors.

    The list of authors should include all those who can legitimately claim authorship. This is all those who:

      1. Made a substantial contribution to the concept or design of the work; or acquisition, analysis or interpretation of data,
      2. Drafted the article or revised it critically for important intellectual content,
      3. Approved the version to be published,
      4. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.

    Authors should meet the conditions of all of the points above. When a large, multicentre group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship.

    Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship, although all contributors who do not meet the criteria for authorship should be listed in the Acknowledgments section. Please refer to the International Committee of Medical Journal Editors (ICMJE) authorship guidelines for more information on authorship.

    2.3 Acknowledgements

    All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, or a department chair who provided only general support.

    Please supply any personal acknowledgements separately to the main text to facilitate anonymous peer review.

    2.3.1 Writing assistance

    Individuals who provided writing assistance, e.g. from a specialist communications company, do not qualify as authors and so should be included in the Acknowledgements section. Authors must disclose any writing assistance – including the individual’s name, company and level of input – and identify the entity that paid for this assistance. It is not necessary to disclose use of language polishing services.

    Please supply any personal acknowledgements separately to the main text to facilitate anonymous peer review.

    2.4 Funding

    Journal of Generic Medicines requires all authors to acknowledge their funding in a consistent fashion under a separate heading. Please visit the Funding Acknowledgements page on the SAGE Journal Author Gateway to confirm the format of the acknowledgment text in the event of funding, or state that: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. 

    2.5 Declaration of conflicting interests

    It is the policy of Journal of Generic Medicines to require a declaration of conflicting interests from all authors enabling a statement to be carried within the paginated pages of all published articles.

    Please ensure that a ‘Declaration of Conflicting Interests’ statement is included at the end of your manuscript, after any acknowledgements and prior to the references. If no conflict exists, please state that ‘The Author(s) declare(s) that there is no conflict of interest’. For guidance on conflict of interest statements, please see the ICMJE recommendations here.

    2.6 Research ethics and patient consent

    Medical research involving human subjects must be conducted according to the World Medical Association Declaration of Helsinki.

    Submitted manuscripts should conform to the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, and all papers reporting animal and/or human studies must state in the methods section that the relevant Ethics Committee or Institutional Review Board provided (or waived) approval. Please ensure that you have provided the full name and institution of the review committee, in addition to the approval number.

    For research articles, authors are also required to state in the methods section whether participants provided informed consent and whether the consent was written or verbal.

    Information on informed consent to report individual cases or case series should be included in the manuscript text. A statement is required regarding whether written informed consent for patient information and images to be published was provided by the patient(s) or a legally authorized representative.

    Please also refer to the ICMJE Recommendations for the Protection of Research Participants.

    All research involving animals submitted for publication must be approved by an ethics committee with oversight of the facility in which the studies were conducted. The journal has adopted the Consensus Author Guidelines on Animal Ethics and Welfare for Veterinary Journals published by the International Association of Veterinary Editors.

    2.7 Clinical trials

    Journal of Generic Medicines conforms to the ICMJE requirement that clinical trials are registered in a WHO-approved public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. The trial registry name and URL, and registration number must be included at the end of the abstract.

    2.8 Reporting guidelines

    The relevant EQUATOR Network reporting guidelines should be followed depending on the type of study. For example, all randomized controlled trials submitted for publication should include a completed CONSORT flow chart as a cited figure and the completed CONSORT checklist should be uploaded with your submission as a supplementary file. Systematic reviews and meta-analyses should include the completed PRISMA flow chart as a cited figure and the completed PRISMA checklist should be uploaded with your submission as a supplementary file. The EQUATOR wizard can help you identify the appropriate guideline.

    Other resources can be found at NLM’s Research Reporting Guidelines and Initiatives.

    2.9 Data

    SAGE acknowledges the importance of research data availability as an integral part of the research and verification process for academic journal articles.

    Journal of Generic Medicines requests all authors submitting any primary data used in their research articles to be published in the online version of the journal, or provide detailed information in their articles on how the data can be obtained. This information should include links to third-party data repositories or detailed contact information for third-party data sources. Data available only on an author-maintained website will need to be loaded onto either the journal’s platform or a third-party platform to ensure continuing accessibility. Examples of data types include but are not limited to statistical data files, replication code, text files, audio files, images, videos, appendices, and additional charts and graphs necessary to understand the original research. The editor may consider limited embargoes on proprietary data. The editor can also grant exceptions for data that cannot legally or ethically be released. All data submitted should comply with Institutional or Ethical Review Board requirements and applicable government regulations. For further information, please contact the editorial office at gabriella.anderson@sagepub.co.uk

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    3. Publishing Policies

    3.1 Publication ethics

    SAGE is committed to upholding the integrity of the academic record. We encourage authors to refer to the Committee on Publication Ethics’ International Standards for Authors and view the Publication Ethics page on the SAGE Author Gateway.

    3.1.1 Plagiarism

    Journal of Generic Medicines and SAGE take issues of copyright infringement, plagiarism or other breaches of best practice in publication very seriously. We seek to protect the rights of our authors and we always investigate claims of plagiarism or misuse of published articles. Equally, we seek to protect the reputation of the journal against malpractice. Submitted articles may be checked with duplication-checking software. Where an article, for example, is found to have plagiarised other work or included third-party copyright material without permission or with insufficient acknowledgement, or where the authorship of the article is contested, we reserve the right to take action including, but not limited to: publishing an erratum or corrigendum (correction); retracting the article; taking up the matter with the head of department or dean of the author's institution and/or relevant academic bodies or societies; or taking appropriate legal action.

    3.1.2 Prior publication

    If material has been previously published it is not generally acceptable for publication in a SAGE journal. However, there are certain circumstances where previously published material can be considered for publication. Please refer to the guidance on the SAGE Author Gateway or if in doubt, contact the Editor at the address given below.

    3.2 Contributor's publishing agreement

    Before publication, SAGE requires the author as the rights holder to sign a Journal Contributor’s Publishing Agreement. SAGE’s Journal Contributor’s Publishing Agreement is an exclusive licence agreement which means that the author retains copyright in the work but grants SAGE the sole and exclusive right and licence to publish for the full legal term of copyright. Exceptions may exist where an assignment of copyright is required or preferred by a proprietor other than SAGE. In this case copyright in the work will be assigned from the author to the society. For more information please visit the SAGE Author Gateway

    3.3 Open access and author archiving

    Journal of Generic Medicines offers optional open access publishing via the SAGE Choice programme. For more information please visit the SAGE Choice website. For information on funding body compliance, and depositing your article in repositories, please visit SAGE Publishing Policies on our Journal Author Gateway.

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    4. Preparing your manuscript for submission

    4.1 Formatting

    The preferred format for your manuscript is Word. LaTeX files are also accepted. Word and (La)Tex templates are available on the Manuscript Submission Guidelines page of our Author Gateway.

    4.2 Artwork, figures and other graphics

    For guidance on the preparation of illustrations, pictures and graphs in electronic format, please visit SAGE’s Manuscript Submission Guidelines.  

    Figures supplied in colour will appear in colour online regardless of whether or not these illustrations are reproduced in colour in the printed version. For specifically requested colour reproduction in print, you will receive information regarding the costs from SAGE after receipt of your accepted article.

    4.3 Supplementary material

    This journal is able to host additional materials online (e.g. datasets, podcasts, videos, images etc) alongside the full-text of the article. For more information please refer to our guidelines on submitting supplementary files.

    4.4 Reference style

    Journal of Generic Medicines adheres to the SAGE Harvard reference style. View the SAGE Harvard guidelines to ensure your manuscript conforms to this reference style.

    If you use EndNote to manage references, you can download the SAGE Harvard EndNote output file.

    4.5 English language editing services

    Authors seeking assistance with English language editing, translation, or figure and manuscript formatting to fit the journal’s specifications should consider using SAGE Language Services. Visit SAGE Language Services on our Journal Author Gateway for further information.

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    5. Submitting your manuscript

    Journal of Generic Medicines is hosted on SAGE Track, a web based online submission and peer review system powered by ScholarOne™ Manuscripts. Visit http://mc.manuscriptcentral.com/jgm to login and submit your article online.

    IMPORTANT: Please check whether you already have an account in the system before trying to create a new one. If you have reviewed or authored for the journal in the past year it is likely that you will have had an account created.  For further guidance on submitting your manuscript online please visit ScholarOne Online Help.

    5.1 ORCID

    As part of our commitment to ensuring an ethical, transparent and fair peer review process SAGE is a supporting member of ORCID, the Open Researcher and Contributor ID. ORCID provides a persistent digital identifier that distinguishes researchers from every other researcher and, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between researchers and their professional activities ensuring that their work is recognised.

    We encourage all authors to add their ORCIDs to their SAGE Track accounts and include their ORCIDs as part of the submission process. If you don’t already have one you can create one here.

    5.2 Information required for completing your submission

    You will be asked to provide contact details and academic affiliations for all co-authors via the submission system and identify who is to be the corresponding author. These details must match what appears on your manuscript. At this stage please ensure you have included all the required statements and declarations and uploaded any additional supplementary files (including reporting guidelines where relevant).

    5.3 Permissions

    Please also ensure that you have obtained any necessary permission from copyright holders for reproducing any illustrations, tables, figures or lengthy quotations previously published elsewhere. For further information including guidance on fair dealing for criticism and review, please see the Copyright and Permissions page on the SAGE Author Gateway.

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    6. On acceptance and publication

    6.1 SAGE Production

    Your SAGE Production Editor will keep you informed as to your article’s progress throughout the production process. Proofs will be sent by PDF to the corresponding author and should be returned promptly.  Authors are reminded to check their proofs carefully to confirm that all author information, including names, affiliations, sequence and contact details are correct, and that Funding and Conflict of Interest statements, if any, are accurate. Please note that if there are any changes to the author list at this stage all authors will be required to complete and sign a form authorising the change.

    6.2 Online First publication

    Online First allows final articles (completed and approved articles awaiting assignment to a future issue) to be published online prior to their inclusion in a journal issue, which significantly reduces the lead time between submission and publication. Visit the SAGE Journals help page for more details, including how to cite Online First articles.

    6.3 Access to your published article

    SAGE provides authors with online access to their final article.

    6.4 Promoting your article

    Publication is not the end of the process! You can help disseminate your paper and ensure it is as widely read and cited as possible. The SAGE Author Gateway has numerous resources to help you promote your work. Visit the Promote Your Article page on the Gateway for tips and advice. In addition, SAGE is partnered with Kudos, a free service that allows authors to explain, enrich, share, and measure the impact of their article. Find out how to maximise your article’s impact with Kudos

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    7. Further information

    Any correspondence, queries or additional requests for information on the manuscript submission process should be sent to the Journal of Generic Medicines editorial office as follows:

    Brian Tempest, Managing Editor, Journal of Generic Medicines, 1341 Connecticut Ave, NW-3rd Floor, Washington, DC 20036, USA. 
    Email: brian.tempest@clara.co.uk

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