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).
Best Answer
"Normative document" and "regulatory document" are not the same.
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
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.