Impact on the Availability of Food Supplements and Medicines in the Russian Federation during Legislative Changes in 2010: A Case Study

Round 1

Reviewer 1 Report

The author investigated the legislative change burden on the availability of food supplements and medicines in the RF during the most turbulent period from 2010 to 2012. It is an interesting study, and the research method is very promising. The work can be further improved based on the following:
a) Please, make the abstract one paragraph, ok
b) Provide more information about the availability food supplements and medicines, so that there would be stronger case to support why the MA Pathway is relevant. In this, make sure to provide 1) the various food supplements available in the market; 2) the various associated medicines in the market; 3) how food supplements and medicines relate, and 4) how why there is need to investigate such relationship. (Provide a table, listing major manufacturers of food supplements and medicines, and some of their products....one column for type (i.e., food supplement, medicine), one column for manufacturer name, one column for some major products, )...refer to this in the introduction ok
c) please, in the introduction, kindly reduce the information about legislation, so that it will balance with that of food supplements and medicine, in terms of emphasis.

d) The results are very ok. Please, work through it, and remove 'we', because this is a sole authored work. Check the entire manuscript for this.
e) The discussion is very promising. Please, go through the discussion, and make sure to insert (Refer to Figure x) at all the places where specific figure is been discussed. Please, all the figures mentioned in the results must be captured in the discussion. Also, make effort to link the discussion to the Table 1.
f) The conclusion, please kindly provide a direction for future studies.

Look forward to your revised manuscript.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 2 Report

At least a major revision is required to accept the manuscript for publication.

L32: [1] is missing.

L33, L163, L169, L192, L209, L211, L216, L220, L221, L234, L272, L293, L294, L345, L371: In terms of the objectivity of a scientific research, too many "we did sth" should be changed to “sth be done”

L36: If there are a limited number of references, please give some.

L39-41: please give more details about “used its own general principles.”

L115: It is more customary to place the figure titles at the bottom of the figure.

L116: The figure confuses the readers. Some improvements can be made, at least including using the same arrow format in Figure 2 and Figure 3.

L151: the Materials and Methods part confuses readers. It seems that a lot of inappropriate content has been put here.

L182-184: The key of this part should focus on the difference between these two pathways, and the resulting changes caused by them. However, from the current statement, this is not enough.

L232: It seems that the results and discussion here are relatively simple and general.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 3 Report

This is an interesting case study of regulatory changes regarding food and drug markets in the Russian Federation between 2010 and 2012. The manuscript has great potential as a contribution to the regulatory literature. However, in its present form, it is not suitable for publication for the following reasons:

1.  The abstract in the manuscript and that on the website are substantially different.

2. The introduction is very disjointed with little continuity between paragraphs. It is also quite long. The information about context could be tightened up and shortened.

3. Reference 1 is missing in  the text.

4. Just because there was a decline in the number of approved products after the 2010 regulatory change doesn't mean anything without reference to drug approval rates in other countries. For instance, in the US, there were 28 new molecular entities (NMEs) approved in 2011. In 2012, there were 39 NMEs and 27 NMEs approved in 2013. It would be extremely helpful for the reader to compare RF's rate with other countries.

5. References are not in MDPI style. Cyrillic citations need translated into English.

Thank you for the opportunity to review this manuscript.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

Very promising revised manuscript
Please note the following minor observations to consider at the proof stage
-Line 204: ...but the confounders were deemed important

Please try to reduce the paragraphs, it is not the best practice to paragraph tiny points...move points together where there relate, to a theme or idea ok...please implement this from introduction, through the results, discussion, and conclusions (this conclusion section should be one paragraph)
Please, kindly go through to check spelling errors, grammar errors, there are a few here and there.
After this, the work can be accepted for publication.

Author Response

Please note the following minor observations to consider at the proof stage
-Line 204: ...but the confounders were deemed important

IT IS CORRECTED

Please try to reduce the paragraphs, it is not the best practice to paragraph tiny points...move points together where there relate, to a theme or idea ok...please implement this from introduction, through the results, discussion, and conclusions (this conclusion section should be one paragraph)

DONE

Please, kindly go through to check spelling errors, grammar errors, there are a few here and there.

RECHECKED

 

Reviewer 3 Report

This version is much better. Just a couple of suggestions.

Ln 31: it is customary to spell out the first use of an abbreviation in the full text. You first present ones for NPL and FS in the abstract, but include them in the first paragraph.

Ln 39: "Until" instead of "till".

Ln 49: you introduce MA. Please spell it out the first time with the abbreviation in parenthesis.

Lns 143-158: seem misplaced. Include in the introduction.

Ln 290: you add data from Ireland, an external comparator. Thank you.

Additional references and their translation into English is appreciated.

References are not in MDPI style.

Thank you for the opportunity to review this updated version.

Author Response

Ln 31: it is customary to spell out the first use of an abbreviation in the full text. You first present ones for NPL and FS in the abstract, but include them in the first paragraph.

DONE

Ln 39: "Until" instead of "till".

DONE

Ln 49: you introduce MA. Please spell it out the first time with the abbreviation in parenthesis.

DONE

Lns 143-158: seem misplaced. Include in the introduction.

DONE

Ln 290: you add data from Ireland, an external comparator. Thank you.

Additional references and their translation into English is appreciated.

REFERENCES ADDED

References are not in MDPI style.

REFERENCES ADJUSTED