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Author Guidelines

These instructions for authors were compiled based on CSE’s White Paper on Promotion Integrity in Scientific Journal Publications, 2023, and ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, January 2024.

By submitting this article, the authors confirm that they agree with the following terms and policies.

Regulatory Research and Medicine Evaluation covers the latest achievements in standardisation and quality control of various groups of medicines, development and improvement of pharmaceutical test methods, approaches to medicine quality evaluation, including approaches to establishment of medicine interchangeability. The journal discusses new high-tech methods used in preclinical and clinical studies, current pharmacological and clinical medicine issues, rational use of drugs based on personalised medicine principles.

The journal publishes original research articles, reviews, brief communications, and methodical approaches pertaining to one of the following specialist fields:

Life Sciences: 

• 3.3.6 Pharmacology, clinical pharmacology (medical sciences), approved by the Higher Attestation Commission as of 11.04.2023

Pharmaceutical Sciences: 

• 3.4.1 Pharmaceutical formulation and manufacturing (pharmaceutical sciences), approved by the Higher Attestation Commission as of 11.04.2023
• 3.4.2 Pharmaceutical chemistry and pharmacognosy (pharmaceutical sciences), approved by the Higher Attestation Commission as of 11.04.2023
• 3.4.3 Pharmaceutical management (pharmaceutical sciences), approved by the Higher Attestation Commission as of 11.04.2023

Chemical Sciences: 

• 1.4.2 Analytical chemistry (chemical sciences)

The editors will consider a manuscript on a non-pharmacopoeial herbal drug or a screening study to identify a novel molecule only if the authors provide substantial evidence supporting the potential medicinal use of this herbal drug or novel molecule.

The authors may support their submission with evidence from scientific publications, data on the pharmaceutical use of the active substance of interest, references to pharmacopoeias that include monographs on the herbal drug / active substance / medicinal product, the results of the authors’ own research, etc.

The editors are entitled to reject the manuscript if the supporting evidence is inadequate.

The journal accepts materials from post-graduate students, doctoral students, specialists and experts in the above-mentioned fields.

The publication of articles is free of charge; no remuneration is offered to authors.

The journal does not accept articles based on the proceedings of virtual scientific conferences.

In order to be published an article should be drawn up in accordance with the rules for authors, should pass the anti-plagiarism test, undergo double-blind peer review, and be recommended for publication at the Editorial Board meeting. Papers that are not adequately drawn up or do not fall within the scope of the journal may be rejected by the editorial team without peer review.

There should be no illegal borrowings (plagiarism) in a paper. The number of references to own works (self citation) should not exceed 20 %.

The citation of articles published earlier in the “Regulatory Research and Medicine Evaluation” (i.e. journal self-citation which reduces its rating) should be avoided unless it seems necessary (e.g. an article is a continuation of a previously published paper).

Articles rejected by the Editorial Board cannot be submitted for a second time, and will not be reviewed.

Updated 04 June 2024

I. Recommendations for authors before submission of an article

Submission of an article to the “Regulatory Research and Medicine Evaluation” implies that:

- the article was not published earlier in another journal;

- the article is not being reviewed for publication in another journal;

- all co-authors agree to the publication of the current version of the article.

When preparing an article it is recommended to adhere to the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (International Committee of Medical Journal Editors, ICMJE) http://www.icmje.org/recommendations/translations/russian2016.pdfand use the following guidelines and charts developed by international organisations in the field of healthcare (EQUATOR, Enhancing the Quality and Transparency of Health Research):  

- when preparing articles that describe the findings of randomised clinical trials – «CONSORT 2010 checklist of information to include when reporting a randomised trial» http://www.consort-statement.org/Media/Default/Downloads/Translations/Russian_ru/Russian%20CONSORT%20Flow%20Diagram.pdf;

- when preparing articles that describe the results of observational studies – «The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies» http://www.equator-network.org/reporting-guidelines/strobe/;

- when preparing systematic reviews – «PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)» http://www.prisma-statement.org/documents/PRISMA%20Russian%20flow%20diagram.pdf;

- when preparing clinical case descriptions – «The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development» http://www.equator-network.org/reporting-guidelines/care/;

- when preparing articles reporting qualitative research – «SRQR (Standards for reporting qualitative research)» https://www.equator-network.org/reporting-guidelines/srqr/;

- when preparing articles reporting the results of prognostic studies – STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies http://www.equator-network.org/reporting-guidelines/stard/.

For quality assessment of narrative review articles we recommend to use SANRA scale.

Articles should be carefully checked and edited. Authors are fully responsible for the linguistic accuracy of the text, particularly for the correct use of scientific terms. The editorial staff may reduce an article in size, maintaining the main idea.

The editors reserve the right to reject articles containing promotional materials, including indirect advertising.

If a paper describes the results of a trial involving animal or human participants, it should include a statement that all the stages of the trial were carried out in compliance with relevant laws and were approved by the ethics committee (and provide the title, number, and date of the supporting document).

__________________________________________________

II. Structure and format of an article

The editorial staff of the “Regulatory Research and Medicine Evaluation” recommend that authors use templates for a research article or a review.

Reviews should not exceed 60,000 characters (with spaces), whereas original research articles should not exceed 45,000 characters (with spaces) including the abstract, the main text of the paper, the title of the paper, titles of tables, tabular data, figure captions, references.

The formatting of the main text of the paper is done using 2.0 cm top and bottom margins, 3.0 cm left margin, 1.5 cm right margin, Times New Roman font, 14 point size, and one-and-a-half line spacing. The formatting of the abstract, key words, information for citation, corresponding author, tables, figure captions, acknowledgements, disclosure, and references is done using Times New Roman font, 12 point size, and single spacing for information about the authors. 

1) The UDC (Universal decimal classification). The UDC number is given in the upper left-hand corner on the first page of the article. The author chooses UDC in accordance with the topic of the article.

2) The title of the article. The title should reflect the subject matter of the article, be informative and adequately reflect the main aim that the author pursues to explore the topic. The title of the article should not contain any abbreviations except for those that are generally accepted.

3) The author’s (authors’) last name(s) and initial(s). The list of authors should contain the authors’ initials followed by their last names. If there are several authors, the Authors contributionsection, which is placed at the end of the paper, should describe the actual contribution of each co-author (see p. 13 of the Author Guidelines). The authors should determine for themselves the criteria defining the order in which the authors are listed. A superscript asterisk placed to the right of the last name indicates the corresponding author, and a superscript number indicates affiliation (if any of the authors work in different institutions).

4) The author’s (authors’) affiliation includes the full name of the organisation (as stated in its Charter) and its full postal address (house number, street name, city, postal code, country). Authors have to indicate all places of work related to the study. If the article was written by authors working for different institutions, it is necessary to indicate each author’s affiliation by a superscript index.

5) Corresponding author.  The name of the corresponding author should be given as “the first name, the first letter of the patronymic, the last name” (Ivan I. Ivanov); e-mail.

6) Abstract. An abstract should contain about 150–300 words. It should be as informative as possible in order to give a clear idea of the article’s contents. An abstract of a research article should be well-structured: a brief summary of the relevance of the topic should be followed by subsections devoted to the aim of the study, materials and methods, results and conclusions. The headings of these subsections are highlighted in bold (see template). When drafting an abstract of a review article, it is not necessary to single out individual headed subsections; however, the logic of presentation should be the same as in the article itself (see template). An abstract should not contain any references to literature sources. It is not recommended to use abbreviations.

7) Key words – are the most relevant words or word-combinations related to the research topic which reflect the specifics of the topic, objects and results of the research. Keywords are used to search for articles in databases.

The list of key words should include 5-10 words or word combinations supplementing the abstract and title of the paper. One word combination may contain maximum 3 words. Words making part of a word combination should not be separated by a comma, words in quotes should not be used. Key words should be given in the nominative case and separated by a semicolon. There is no full stop at the end of the key words list. When selecting keywords for an article, it is recommended to use the MeSH (Medical Subject Headings – medicine’s controlled vocabulary thesaurus): https://meshb.nlm.nih.gov/search; https://meshb.nlm.nih.gov/MeSHonDemand

8) Reference for citation (see template).

9) Funding. 

10) Disclosure. This section lists any relationships or areas of interest that could directly or indirectly affect the study and objective assessment of the study’s results. Authors have to inform the editorial team about any real or potential conflict of interest (Disclosure form) by describing it in an appropriate section of the article. If there is no conflict of interest, authors should also report this (see template). Please note that the conflict of interest related to the research or preparation of the paper does not constitute grounds for rejection of the paper. The disclosure of the funding sources suggests the transparency of the authors’ positions and the reliability of the study results.

Typical examples of potential conflicts of interest that are directly or indirectly related to the study:

- doing work or counselling;

- receiving speaking fees (symposia, conferences, lectures, etc.);

- receiving financial support for participation in scientific events;

- receiving financial support for educational programmes;

- holding positions in the advisory board, board of directors, or other management positions;

- membership in organisations related to research topic;

- financial relationships (for example, investment, shared ownership);

- financial interest on the part of relatives;

- intellectual property rights (for example, patents, copyrights and fees for such rights);

- the author’s personal beliefs, including religious ones.

The “Disclosure” section should contain only those facts that can affect presentation of results.

11) The main text of the article. The journal adopted the IMRaD format for original research (results of the authors’ own research). The IMRaD format (introduction, methods, results and discussion) implies that the paper should contain the following sections: introduction, materials and methods, results and discussion, conclusion.

Review articles (results of literature reviews) should have the following layout:

- introduction reflecting the relevance of the problem and ending with the statement of the study’s aim and objectives;

- the main part divided into sections (if necessary) and containing the results of the study and their discussion;

- conclusions (or final statement).

Sections of review articles may be given any titles the authors deem appropriate.  

Contracted and abbreviated words can be used in the main body of the text if they are accompanied by the full form when first used. Family names of foreign authors should be cited using original spelling. Units of measurement and other numeric values should be given according to the International System of Units.

An article could be accompanied by a glossary of terms and abbreviations that should be placed at the beginning of the article.

Citation. Citations given in articles should be verified and properly formatted. In-text references to literature sources should be numbered in square brackets. References to nonindexed sources (see “References”) are given as footnotes.

When making reference to a paper and its authors, the authors’ initials should be given before their names (e.g., “According to P.M. Ivanov et al. [25], as well as J.K. Jonson et al. [26] ...”). Foreign names should be written the same way as in the cited source.

A full stop is not placed after: the title of the article, subtitles, key words, titles of tables, units of measurements (s – second, g – gram, min – minute, d – day, deg – degree), some numerals (mln – million, bn – billion, tn – trillion),  references to electronic media, and subscripts (Т_melt – melting temperature, Т_phtr – phase transition temperature). A full stop is placed after the titles of pictures and notes to the tables.

An introduction. The size of this part should not exceed 20 % of the size of the main text. The introduction should contain a brief update on the current state of the problem, justification of its relevance, statement of the study’s aim and objectives. The aim of the study should be formulated in line with the title of the article.

Materials and methods. This section is required for original research. It should include a detailed description of the materials used, information about the objects and methods of the study. Authors should justify their choice of test objects.

It is necessary to provide accurate detailed information about the source of any animals, cell cultures, microbial strains, etc. used in the study.

Authors should indicate the grade and manufacturer of any reagents used, as well as the brand and manufacturer of instruments and equipment used in the experiments. Company names should be given in the original spelling. If possible, international non-proprietary names of medicines should be given instead of brand names.

If an article describes a clinical trial, authors should provide confirmation that the trial was approved by the institutional ethics committee (stating the document’s title and number) and that it is consistent with the Declaration of Helsinki, 1975. Articles may not include any patient identifying information (patients’ initials and last names, medical record numbers). Photos submitted for publication should not allow identification of patients either.

Authors should inform patients (or their parents/caregivers) about potential publication of materials, including details of their diseases and information on diagnostic and treatment methods, in print and electronic media, as well as about assurances of confidentiality, and availability of publications in the Internet. Authors have to include a statement in the article that they received written informed consent from the patients to dissemination of information.

When describing animal experiments, authors have to include confirmation that the management and use of laboratory animals complied with international, national or institutional norms of ethical treatment of animals (indicating the title and number of the study’s ethical approval protocol).

Authors have to describe the conditions of experiments, the sequence of operations, and the software used in the study. The study methods should be described in sufficient detail so as to ensure their reproducibility, though there is no need to dwell upon the well-known methods ‒ in this case it would suffice to include a reference to an appropriate literary source. Authors should provide detailed information on randomisation, describe the methods used for ensuring “blind” control and statistical analysis of results.

Results and discussion.  This section should include a detailed analysis of the obtained results. All tables and pictures included in the paper should be mentioned in the text and be arranged in the order of mentioning. Tabulated data and figure captions should not repeat themselves.

The presentation of results should consist in identifying the observed trends, and not in simple retelling of the contents of the tables and graphs. It is recommended that authors present results using the past tense and affirmative sentences. The results and their discussion may be presented in two separate sections “Results” and “Discussion of results”.

Tables should be editable and created in Microsoft Office applications.

Each table should have a title that includes its number and name. “Table 2. Description of vital processes”. There is no full stop at the end of the table’s heading. Headings are aligned to the left.

Tables are numbered using Arabic numerals in the order of their appearance in the text. If there is only one table in the text, it should be numbered nevertheless. References to the tables are made in the following way: “Table 3 indicates...” or “It is indicated... (Table 3)”.

The names of columns and rows are highlighted in bold. There should not be any empty spaces in tables. It is not recommended to use abbreviations in tables, but if it is necessary to use abbreviations, their interpretation is given in the notes to the table.

All data presented in tables should correspond to those in the text of the article.

Pictures (graphs, photographs, screenshots, charts) may be either coloured or black-and-white. Electronic versions of pictures and photos should have resolution of at least 300 dots per inch, and jpeg, tifF, or PNG format. Micrographs should have internal scale markers. Captions to micrographs should state the scale of magnification (if necessary) and the staining method.

Each picture should have a caption that includes its number and name. “Picture 2. Description of vital processes.”. There should be a full stop at the end of the caption. Pictures are numbered using Arabic numerals in the order of their appearance in the text. If there is only one picture in the text, it should be numbered nevertheless. References to the pictures are made in the following way: “Picture 3 shows...” or “It is shown... (Picture 3)”.

The number of symbols in graphs and photographs should be minimal. All explanations should be provided in the caption.

 Mathematical formulas, equations and symbols.

Standalone mathematical formulas (that are placed on separate lines) should be generated by MathType as one piece. Formulas made of different elements, such as tables, text or a filled-in box, are unacceptable. The article should not contain any formulas in the form of graphic elements (pictures). Formulas generated by MathType should use the standard font type and size, placement of symbols and general rules of formula creation set by default by the programme:    

- digits should be printed using upright type;

- Latin letters denoting values (alphabetical symbols) should be printed in italics; 

- abbreviated mathematical symbols (e.g., sin, cos, lg, lim, max) should be printed in block letters;

- Russian letters (used both in formulas and in subscripts/superscripts) should be printed in block letters; there is no full stop at the end of a subscript/superscript;

- subscripts/superscripts should be printed in block letters, e.g., N_fin (i.e N_final), C_max, S_avg;

- Greek letters should be printed in block letters;

- symbols of chemical elements should be printed in block letters.

Simple mathematical and chemical formulas (e.g., a₂ + b₂ = c₂; H₂SO₄) and individual variables or symbols should be printed as text and not included into filled-in boxes (generated by a computer programme).

If an equation is too long to fit into one line, it should be carried forward to the next line after the equal mark (=) or plus mark (+), minus mark (‒), multiplication mark (×), or another mathematical mark, provided that the mark is repeated at the beginning of the new line.

Numeric symbols and numerical factors should be explained immediately below the formula/equation in the same order as they appear in the formula/equation. Formulas and equations are assigned with sequential numbers that run through the whole text of the article.  Authors should use Arabic numerals in brackets for numbering and place them at the right end of the line.

For example:

A single formula/equation is denoted as (1). In-text references to formula/equation numbers should be provided in Arabic numerals in brackets. Decimal places in digits are separated by a full stop, and not by a comma (0.25 instead of 0,25), the reverse is true for the Russian text (0,25 instead of 0.25).

Latin names of objects of research are written according to the general rules of taxonomic nomenclature: binary names of species and higher taxon names – in italics (Valeriana officinalis L., Valeriana genus, Valerianaceae family; Bacillus anthracis, Bacillus genus, Bacillaceae family). When first used in the text genus and species names are given in full, further on genus names are given by the first capital letter, and species names are given in full (B. anthracis).

Names and symbols of genes are given in italics, and names of gene products – in block letters starting with a capital letter, e.g. genes: fos, c-myc, ATM; proteins: Fos, c-Myc, ATM. Names of mobile elements, e.g. hobo-element, and the three first letters of restriction sites are given in italics, HindIII. Names of phages and viruses are printed in block letters in Latin.     

Conclusion. The contents of this part should reflect the aim of the study. The statements found elsewhere in the paper should not be repeated in this part word for word. The CONCLUSION part may contain:

- results of the information analysis, which support theoretical and practical relevance of the study;

- practical conclusions of the study;

- recommendations on the practical use of information provided in the paper (e.g., recommendations on prevention and treatment of diseases, conducting preclinical and clinical studies, quantitative and qualitative analysis of medicinal products, etc.);

- outstanding issues and potential areas for further research that could be addressed in the future.

This part may be arranged as a numbered list, in which case the name of this part should be changed to Conclusions.

12) References. The journal uses the Vancouver style, i.e. references are numbered consecutively in the order they are first used in the text. References should include only indexed Russian and foreign sources preferably published over the last 5-7 years: articles from scientific journals and collections of research papers (including electronic ones), monographs, patents. In general, the number of references should not exceed 60 (a larger number of references is acceptable, but has to be justified). 

References to articles that have been accepted for publication but have not been published yet should include the statement: “in print”. Authors should obtain a written confirmation that such articles have been indeed accepted for publication.

If there are 6 or fewer authors, all of them are mentioned in the bibliographic description, if there are more than 6 authors, only the first 6 are mentioned followed by et al. If only editors of the book are mentioned, “eds.” or “ed.” should be placed after the editors’ names. There is no comma between the author’s last name and initials, there are no full stops after the initials.

Names of journals, books, monographs, collections of papers are italicised. Bibliographic descriptions of journal articles should state the date of publication, volume and issue of the journal, and page numbers. The number of the last page represents only the range that changes, e.g., 482-6 instead of 482-486, or 359-63 instead of 359-363).

Bibliographic descriptions of Russian sources should be duplicated in Latin script. Last names of referenced authors should be transliterated (using the BSI standard). Journal names should be referenced in English (if there is an official translation) or transliterated. The following note should be placed at the end of the reference: (In Russ.).

Reference should include a DOI, EDN.

Authors should verify bibliographic descriptions of the referenced sources.

Examples of references

Articles from foreign journals:

Ilango S, Pillans P, Peel NM, Scott I, Gray LC, Hubbard RE. Prescribing in the oldest old inpatients: a retrospective analysis of patients referred for specialist geriatric consultation. Intern Med J.2017;47(9):1019–25. https://doi.org/10.1111/imj.13526

Monographs in a foreign language:  

1-3 authors:

Beck S, Klobes F, Scherrer C. Surviving Globalization? Perspective for the German Economic Model. Berlin: Springer; 2005.

Hankenson FC. Critical care management for laboratory mice and rats. New York: CRC Press; 2013.

Indication of the name of the editor or compiler:

Osipov VG, Rybakovsky LL, eds. Demographic development of Russia in the 21st century. Moscow: Ekon-Inform; 2009 (In Russ.).

Creasey RK, Resnik R, eds. Maternal-Fetal Medicine: Principles and Practices. 5th ed. Philadelphia: WB Saunders; 2004.

A chapter of a monograph or a collected book:

Maslova OV, Sen’ko OV, Stepanov NA, Efremenko EN. Biocatalytic synthesis of organic acids and plastics based on them. In: Varfolomeev SD, ed. Chemistry of biomass: biofuels and bioplastic. Moscow: Nauchny mir; 2017. P. 621–51 (In Russ.).

Silver RM, Peltier MR, Branch DW. The immunology of pregnancy. In: Creasey RK, Resnik R, eds. Maternal-Fetal Medicine: Principles and Practices. 5th ed. Philadelphia: WB. Saunders; 2004. P. 89–109.

Articles from Russian journals:

Сокова ЕА, Архипов ВВ, Чилова РА, Демидова ОА, Проклова ГФ, Пикуза ТВ. Эффективность и безопасность противоэпилептических лекарственных средств у беременных: фармакогенетические аспекты. Ведомости Научного центра экспертизы средств медицинского применения. 2018;8(2):72–6. Sоkоvа EA, Arkhipov VV, Chilova RA, Demidova OА, Proklova GF, Pikuza TV. Efficacy and safety of antiepileptic drugs during pregnancy: Pharmacogenetic Aspects. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2018;8(2):72–6 (In Russ.). https://doi.org/10.30895/1991-2919-2018-8-2-72-76

Articles from electronic journals:

Chat V, Wu F, Demmer RT, Parvez F, Ahmed A, Eunus M, et al. Association between number of children and carotid intima-media thickness in Bangladesh. PLoS One. 2018;13(11): e0208148. https://doi.org/10.1371/journal.pone.0208148

Monographs in Russian:

Sepiashvili RI, Slavyanskaya TA. WAO white book of allergy 2011–2012: resume. Moscow: Meditsina–Zdorovie; 2011 (In Russ.).

Scientific conference papers:

Scientific research in medicine and pharmacology. Conference proceedings of the international scientific-practical conference. April 25, 2018. Saratov; 2018; No. 3 (In Russ.).

28th European Meeting on Hypertension and Cardiovascular Protection. Barcelona, June 8–11, 2018. Barcelona; 2018.

Bebyakova NА, Evseeva OS, Kuba АА, Feliksova OM, Khromova АV. Analysis of the occurrence of polymorphism T786-C in the elderly. In: Prospects for the development of modern medicine. Voronezh; 2015; Part 2. P. 79–81 (In Russ.).

Patent specifications:

Krivykh MA, Kornilova OG, Kudasheva EYu. Method for producing positive control standard sample of human immunoglobulin to determine anticomplementary activity of preparations of human immunoglobulin, and standard sample of human immunoglobulin to determine anticomplementary activity of preparations of human immunoglobulin. Patent of the Russian Federation No. 2577703; 2016 (In Russ.).

Footnotes. Such literature sources as theses and their summaries, educational and instructional materials, laws and regulations (including pharmacopoeial monographs), state standards, guidelines and recommendations, information from websites, statistical documentation, scientific and technical documentation (including research reports) are not included in the list of references. Reference to these sources should be made in the form of footnotes (MS Word tool "Insert Footnote").

References to regulatory documents should include up-to-date information.

In addition to references to nonindexed sources, footnotes may also include the authors’ comments on some parts of the text.

Examples of footnotes

References to nonindexed sources (summaries of theses¹, theses², educational and instructional materials³, laws and regulations⁴ (including pharmacopoeial monographs⁵), state standards⁶, guidelines and recommendations⁷, information from websites⁸, statistical documentation⁹, scientific and technical documentation (including research reports¹⁰) should be made in the form of footnotes.

Such references should be made using the MS Word tool “References” → “Insert Footnote” (Arabic numerals).

For laws and regulations¹¹, as well as for guidelines and recommendations¹² the footnote should include the name of the document and its bibliographic description.

If the text contains the full official name of the document, information database, or another source, which allows for unambiguous identification of the source (for example, “the article analyses the provisions of the Federal Law of the Russian Federation No. 61-FZ “On Circulation of Medicines”of April 12, 2010), the author need not include information about this source in the footnote, because the information provided in the text is already sufficient.

For materials posted on the Internet and having no official bibliographic description, the footnote should include the web address of the page where the document is located. If the name of the official web site (of an organisation, database, register) is given in the text, the footnote may include only the web address (e.g., “according to the State Register of Medicinal Products”¹⁴).

If the bibliographic description, including the document number, allows for unambiguous identification of the document, the web address of the document is not included¹⁵.

Footnotes are numbered sequentially, each footnote has its own unique number. When the source is mentioned again in the text, it is assigned with a new sequential number. In other words, one and the same source may appear in footnotes as many times as needed, and be assigned with different numbers (for example, 1, 6, 8).

If the information in a footnote repeats the information in the previous footnote, the author may replace the full name of the source with “Ibid.” Example: a reference to the source¹⁶. If the next footnote refers to the same source, the full name of the source need not be repeated¹⁷. In other cases the author should give the full name of the source.

One footnote may include references to several sources¹⁸.

__________________________________________________________________________

 ¹Доренская АВ. Применение метода электрочувствительных зон в фармацевтическом анализе: автореф. дис. … канд. фарм. наук.  М.; 2015.

   ²Сабгайда ТП. Паразитарная система P. vivax: информационно-математическое моделирование как основа анализа и управления ее функционированием: дис. … д-ра мед. наук. М.; 2002. 

   ³Медуницын НВ, Покровский ВИ. Основы иммунопрофилактики и иммунотерапии инфекционных болезней. Учебное пособие. М.: ГЭОТАР-Медиа; 2005.

   ⁴Приказ Минздрава России от 21.03.2014 № 125н «Об утверждении национального календаря профилактических прививок и календаря профилактических прививок по эпидемическим показаниям».

   ⁵Фармакопейная статья 3.3.1.0013.15 Вакцина дизентерийная против шигелл Зонне полисахаридная. Государственная фармакопея Российской Федерации. XIII изд. Т. 3; 2015.

   ⁶ГОСТ Р 56701-2015. Лекарственные средства для медицинского применения. Руководство по планированию доклинических исследований безопасности с целью последующего проведения клинических исследований и регистрации лекарственных средств.

   ⁷Руководство по проведению доклинических исследований лекарственных средств. Ч. 1. М: Гриф и К; 2012.

    Guideline on human cell-based medicinal products (CPMP/BWP/410869/2006). EMA; 2008.

    Guideline on process validation for finished products – information and data to be provided in regulatory submissions (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1). EMA; 2016.

   ⁸Efficacy and tolerance of naked DNA vaccine in patients with chronic B hepatitis (VAC-ADN). https://clinicaltrials.gov/ct2/show/NCT00536627

   ⁹О состоянии здоровья населения Республики Коми в 2009 году: государственный доклад. 2009. http://www.minzdrav.rkomi.ru/left/doc/docminzdr 

   ¹⁰Разработка нового метода диагностики вирусных заболеваний на ранних стадиях. Отчет о НИР (промежуточный). ФБУН ГНЦ ВБ «Вектор» Роспотребнадзора, рук. Нетесова Н.А., исполн.: Евдокимов А.А. и др. М.; 2017. 24 с. № ГР НИР АААА-А16-116040810107-1. Деп. в ЦИТИС 28.02.2017, № ИКРБС АААА-Б17-217022820201-7.

   ¹¹Общая фармакопейная статья 1.1.0019.15 Упаковка, маркировка и транспортирование лекарственного растительного сырья и лекарственных растительных препаратов. Государственная фармакопея Российской Федерации. XIV изд. Т. 1; 2018.

   ¹²Руководство по экспертизе лекарственных средств. Т. 1. М.: Гриф и К; 2013.

   ¹³Гепатит С. Всемирная организация здравоохранения. http://www.who.int/ru/news-room/fact-sheets/detail/hepatitis-c

   ¹⁴https://grls.rosminzdrav.ru

   ¹⁵EMA review of Zinbryta confirms medicine's risks outweigh its benefits (EMA/286850/2018). ЕМА; 2018.

   ¹⁶Руководство по экспертизе лекарственных средств. Т. 1. М.: Гриф и К; 2013.

   ¹⁷Там же.

   ¹⁸ICH Q8(R2) Pharmaceutical Development, 2009.

     ICH Q9 Quality risk management, 2005.

     ICH Q10 Pharmaceutical Quality System, 2009.

     ICH Q11 Development and manufacture of drug Substances (Chemical Entities and Biotechnological/Biological Entities), 2012.

     ICH M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use, 2016.

     Государственная фармакопея Российской Федерации. XIV изд. Т. 2; 2018.

     Тест «Растворение» в разработке и регистрации лекарственных средств. Научно-практическое руководство для фармацевтической отрасли. М.: Перо; 2015.

13) Authors contribution. This section should clarify how each author has contributed to the paper. The International Committee of Medical Journal Editors recommends that authorship be based on the following criteria:

- substantial contributions to the conception or design of the work; acquisition, analysis, or interpretation of data for the work;

- drafting the work and/or revising it critically for important content;

- final approval of the version to be published;

- agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Contributors who played any other role in the preparation of the paper may be listed in the Acknowledgеments part of the paper.

More information about authorship is available on the website of the International Committee of Medical Journal Editors and the European Association of Science Editors.

Sample text.

The wording samples are not exhaustive. It is advisable to highlight unique contributions of each author and provide details on the efforts in preparing the manuscript. For original research articles, please, specify individual experimental steps for the authors who contributed with conducting experiments.

The number of authors in research papers is not limited, however, review papers should not have more than 4‒5 authors, and summaries of individual clinical cases (observations) and brief reports should not have more than 3‒4 authors.

14) Ethics approval / Informed consent (see templates).

15) Acknowledgments. Authors should include here all sources of research funding, as well as acknowledgements for all those who were involved in the study but whose contribution did not qualify them for authorship. Such involvement may include: recommendations. for improving the research, provision of facilities for research, institutional control, provision of financial support, carrying out certain individual tests, provision of materials, reagents or animals for the research, or access to patients (see template).

16) Authors. This section contains full names of authors, their positions, academic degrees and titles, names of the departments and abbreviated names of the organisations they work for, and the ORCID iD in the following format: http://orcid.org/0000-0000-0000-0000.

The names of authors should be given as “First name, initial of the patronymic, last name” (Ivan I. Ivanov) (see template).

__________________________________________________

III. Submission of articles

In order to submit an article, the authors should register at the journal website https://www.vedomostincesmp.ru, fill in the online form, and upload the article in the website section “Submit an article”.

Each paper should be accompanied with the following:

1) Sscanned copy of the referral from the institution where the work was done (cover letter on the corporate letterhead signed by all the authors). If they are from several organisations, the authors should attach referrals from all the organisations;

2) Author information, including full names of all the authors, their academic degrees and ranks, job titles, department and company names, a contact e-mail and telephone number;

3) A confirmation that the article is prepared by a research degree applicant, as the articles by this category of authors are given priority in the publication queue (if applicable).

Electronic copies of the accompanying documents (scanning size: A4 (210 x 297 mm); display type: coloured, 300 dpi resolution; file type: PDF (.pdf)) should be uploaded as additional files to the manuscript via the online submission system. The text of the manuscript as well as the illustrative material should be placed in one MS Word file (*.doc, *.docx). Big tables and pictures may be uploaded as separate files.

Original copies of the cover letter, and the confirmation of enrolment for a research degree should be posted to the following address: 8/2 Petrovsky Blvd, Moscow 127051, Russia (for the attention of Olga F. Fedotova, Managing Editor).

__________________________________________________

IV.  Communication between the journal and the author

The editorial team communicate with the authors via the author who submitted the article.

All articles undergo preliminary evaluation for compliance with the Instructions for authors. If an article does not fulfill the requirements, it may be returned to the author for correction. At this stage an article may also be rejected if it is not in line with the aim and scope of the journal or lacks originality. The decision on the rejection of the article is made by the Executive Editor.  

After checking the article for compliance the Executive Editor sends it to the Editorial Board in order to assign reviewers at the Board’s  regular meeting. The review period is 14 days, but it may be extended at the request of the reviewer. In disputable cases the editorial team may ask some other experts to review the article. Copies of reviews are sent to the author for information.

In the case of two positive reviews the article is sent to the editor for preparation for publication.

If the reviewers and/or editor raise any issues, the author has to make all the necessary corrections within 14 days. If the author fails to submit the corrected article within this time frame, the publication date will be postponed. If the author does not submit the corrected article within 3 months, the editorial team has the right to withdraw the article from publication, of which the author will be duly notified. In this case the author may submit the article again, and it will again undergo the full procedure of preparation for publication.

The final decision on publication of the article or on its rejection is made by the Editorial Board.

If the article is accepted for publication, the author will be sent the final version of the article for approval. The author has to reply within 2 days. If the author does not reply, the article is considered to be approved.

If the article is rejected, the Executive Editor of the journal emails the notification to the author.

__________________________________________________

V. Revision of the editor’s/reviewer’s decision

If the author does not agree with the conclusions or some remarks of the reviewers and/or the editorial team, he/she may challenge the decisions. To do this, the author will have to provide written arguments for each remark and send a letter to the editorial team.

The editorial team encourage resubmission of papers that are potentially acceptable but were rejected because major revision or additional data were required. The editorial team will provide a detailed explanation of what should be corrected in order for the article to be accepted for publication.

__________________________________________________

VI. Actions undertaken by the editorial team upon discovery of plagiarism, data manipulation or falsification

In case the editorial team discover any research misconduct, including plagiarism, data manipulation or falsification, on the part of authors, they adhere to the principles of COPE.

The “Regulatory Research and Medicine Evaluation” uses the following definition of the term “misconduct”: any actions of the researcher, including mistreatment of test objects or intentional manipulation of research data, that result in false interpretation of data, as well as any actions of the researcher that do not comply with ethical and scientific norms.

 The “Regulatory Research and Medicine Evaluation” does not regard the following to be research misconduct: honest mistakes or unintentional discrepancies in the plan, conduction, interpretation or assessment of research methods or results, or misbehavior which is not related to the research.

In case plagiarism, data manipulation or falsification are discovered at any stage of article preparation, the Editorial Board will consider rejection of the paper.

__________________________________________________

VII. Correction of mistakes and article retraction after publication

If an article is found to contain mistakes that affect perception, but do not confound the research results, these mistakes may be corrected by replacing the pdf version of the article and including a statement about the mistake in the pdf file and on the journal’s web page.

If there are mistakes that confound the research results, or there is plagiarism or research misconduct related to data manipulation or falsification, the article may be retracted. The retraction may be initiated by the editorial team, author, organisation or a private individual.

The retracted article is labelled with the “RETRACTED” sign, and the reason for retraction is stated on the article’s page. The notification about article retraction is sent to the indexing databases.

Submission Preparation Checklist

As part of the submission process, authors are required to check off their submission's compliance with all of the following items, and submissions may be returned to authors that do not adhere to these guidelines.

1. Manuscripts are accepted if they have not been published or submitted for publication elsewhere (or this fact is explained in the Commentaries for the editor).

2. The materials have to be submitted in the OpenOffice, Microsoft Word, RTF, or World Perfect format.

3. Internet links are provided as a complete URL, wherever possible.

4. Texts are typed using one line spacing, Times New Roman, 12 pt font. To highlight any fragments use italics rather than underlining (except Internet links). All pictures, graphs and tables are placed in appropriate parts of the text.

5. Texts should follow the stylistic and bibliographic requirements as stated in the Author Guidelines in the “About the journal” section.

6. If you submit an article to a peer-reviewed section of the journal, make sure to fulfill all the requirements for blind peer review.

7. All the authors confirm that they meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship.

Copyright Notice

Authors who have their articles published in this journal agree to the following terms:

1. Authors retain copyright for their work and grant the journal with the right of first publication under Creative Commons Attribution License that allows others to pass on the work provided they include references to the authors and the original publication.

2. Authors retain the right to enter into non-exclusive distribution arrangements allowing the distribution of the original publication (e.g., adding it to an institutional repository or publishing it in a book), provided all the necessary references are included.

3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their personal websites) prior to and during the submission process, as it can lead to a productive discussion and higher citation rates (See The Effect of Open Access).

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