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From the Russian Federal Law on Circulation of Medicines:

The registration dossier shall comprise the following documents:

1) draft designs of primary packages and secondary (retail) packages for the medicinal product;
2) document certifying the compliance of the manufacturer of the medicinal product to be registered with the requirements of the good manufacturing practices, issued by a competent authority of the country of origin of the medicinal product to be registered and certified in the prescribed manner, as translated into the Russian language;
3) draft normative documentation or normative document for the medicinal product or reference to a relevant pharmacopeia monograph;

What if we used regulatory document there? Would this be better?

I sometimes come across the Russian expression "нормативный документ" (normativny document), for instance, in relation to a drug product monograph. I usually translate it as regulatory document. A drug product monograph describes what composition a drug product should have and what requirements it must meet.

I notice that some people translate the same as "normative document". I googled and found that this law also uses this phrase. So, are "normative document" and "regulatory document" synonymous, and if not, what is the difference?


P.S. I've found that the Russian State Guideline on Good Clinical Practice (ГОСТ Р 52379-2005) stipulates the English term "applicable regulatory requirements" as the translation of "нормативные требования" (normativnye trebovaniya).

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    I will have to do more research to write a real answer, but I found this description of what a "normative document" is: Normative documents are those that provide rules, guidelines or characteristics for activities or their results. It is a generic term that covers such documents as standards, technical specifications, codes of practice and regulations. (source) So it seems "normative" is broader than regulatory. – ColleenV Dec 9 '16 at 16:43
  • @ColleenV - thank you! Judging by this, 'normative document' must be an okay translation to describe a drug product pharmacopoeial monograph. – CowperKettle Dec 9 '16 at 16:54
  • It would be "a normative document". and "good manufacturing practices" without "the". – Tᴚoɯɐuo Dec 10 '16 at 17:36
  • @TRomano While I was poking around for usage examples, I found a lot of references to GMP (good manufacturing practices) so I'm not 100% sure the definite article isn't warranted. It appears to be A Thing in the the industry even though a lay person like myself would read it as manufacturing practices that are good. – ColleenV Dec 16 '16 at 13:48
  • @ColleenV: industry jargon is Good Manufacturing Practice (GMP, and note the singular); "the good manufacturing practices" is a misuse of the jargon, and it is also not idiomatic. – Tᴚoɯɐuo Dec 16 '16 at 15:19
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"Normative document" and "regulatory document" are not the same.

a normative document

describes the standards or ideal concepts behind something and the "correct way of doing something, in your pharmaceutical case it would be people in the industry who write this, whereas

a regulatory document

would describe how certain standards are enforced, it would be lawmakers who write this, and may refer to the related normative document.

A normative document might describe different speed limits in differing areas and why it is better to slow down around schools and in neighborhoods. The regulatory document (otherwise known as 'the law') would describe who might enforce speed limits and what happens when someone is caught speeding.

  • The problem is, when I need to write a phrase like "the product meets the regulatory documentation requirements", I use "regulatory" because "normative documentation" seems to be rare in Google and generally "regulatory" feels better for some reason. – CowperKettle Dec 12 '16 at 12:22
  • "Regulatory requirements" is particularly more widespread compared with "normative requirements" on Google Ngram. – CowperKettle Dec 15 '16 at 7:33
  • I think if you look at "regulatory requirements" vs "industry standards" they are closer to each other until the 1990's – Peter Dec 15 '16 at 8:05
  • Note that some normative documents are also regulatory documents but are not made by lawmakers -- in the UK, for example, BS 7671 (Requirements for Electrical Installations) is written by the Institution of Engineering and Technology, is published by the British Standard Institute, and is specifically mentioned in "Approved Document P" (Electrical Safety -- Dwellings) as the standard to which electrical installations should be designed. – LMS Dec 15 '16 at 17:55
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+200

When I looked for usage examples, I found that 'normative' documents are closely tied to the idea of 'regulatory' because they are usually a set of documents that by regulation must meet certain document control standards.

I found this explanation in a document explaining the requirements for a laboratory to be accredited under a particular ISO/IEC standard:

Normative documents are those that provide rules, guidelines or characteristics for activities or their results. It is a generic term that covers such documents as standards, technical specifications, codes of practice and regulations. (Source)

At first, I thought that these two terms were not interchangeable, but then I found some examples of usage that would suggest otherwise:

Essential documents are commonly referred to as regulatory documents. ICH GCP guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.” (Source)

It seems that there is an overlap between two senses of the word "regulatory". When I read "regulatory" my first impression involves government oversight and laws intended to regulate or 'to adjust to a particular specification or requirement'. The co-location I'm most familiar with is "regulatory agency", but government is not the only thing that can regulate. Thermostats regulate temperature and could be called "regulatory devices" (although I don't believe that's common). It is not incorrect to say "regulatory documents", it just may cause a layperson to confuse the term with documents published by the government or required by the government, because that's the context where we most frequently see the word regulatory.

I would use normative documents when I was referring to a set of documents that are intended to make sure a process is consistent and repeatable.

I might use regulatory documents when I was referring to a set of documents intended to make sure that something meets a certain specification of performance, or that are required by law.

The senses of those phrases are so close that I think they are interchangeable for audiences that work in the field. If the audience is the general public, I would avoid regulatory unless you're talking about government rules and laws. The word normative is a less common word and signals to me that there is some technical distinction I should pay attention to.

And, to actually answer the question at hand:

3) draft normative documentation or normative document for the medicinal product or reference to a relevant pharmacopeia monograph;

I would write that with 'normative' but adding the article as TRomano mentioned in a comment:

3) draft normative documentation or a normative document for the medicinal product or reference to a relevant pharmacopeia monograph;

However because it can be argued that there is a slight difference between normative and regulatory in this context, it might be better to include both types of documents/documentation in the list for completeness:

3) draft normative documentation or a regulatory document for the medicinal product or reference to a relevant pharmacopeia monograph;

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