Справочник структурных элементов (регистрационного досье)

English translation: reference book of the structural elements of a registration dossier of a medicinal product

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:Справочник структурных элементов (регистрационного досье)
English translation:reference book of the structural elements of a registration dossier of a medicinal product
Entered by: Frank Szmulowicz, Ph. D.

06:23 Apr 7, 2021
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals / Drug Market Authorization Policies
Russian term or phrase: Справочник структурных элементов (регистрационного досье)
Справочник структурных элементов регистрационного досье лекарственного препарата

TIA!
Yuri Larin
Ukraine
Local time: 16:26
reference book of the structural elements of a registration dossier of a medicinal product
Explanation:
On the classifier of types of documents for the registration dossier of a medicinal product and the reference book of structural elements of the registration dossier of a medicinal product
https://www.russiangost.com/C-8173-8173-general-documents-on...
https://www.russiangost.com/p-375698-decision-159.aspx
Selected response from:

Frank Szmulowicz, Ph. D.
United States
Local time: 10:26
Grading comment
Всем большое спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +3reference book of the structural elements of a registration dossier of a medicinal product
Frank Szmulowicz, Ph. D.
3Guide to organizing and formatting the registration dossier of a p. p.
Carole Wolfe
3General requirements for the modules of the drug registration dossier
Lesia Kutsenko


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
Guide to organizing and formatting the registration dossier of a p. p.


Explanation:
(In my answer, p. p. stands for pharmaceutical product)
Before a drug can be marketed, the regulatory agency has to approve it.
The drug manufacturer has to submit a collection of documents (a dossier) that proves the drug's efficacy, safety, etc. The agency requires that the dossier be structured according to its guidelines.


Example sentence(s):
  • Preparation of regulatory submission for pharmaceutical products by providing guidance on the organization and formatting of product dossier
  • “Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved/registered/marketed in a country.

    Reference: http://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/...
    Reference: http://www.pharmatutor.org/articles/registration-dossier-pha...
Carole Wolfe
United States
Local time: 09:26
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 44
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2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
General requirements for the modules of the drug registration dossier


Explanation:
http://regapharm.com/rules_registration_dossier_formation_ea...

Lesia Kutsenko
Canada
Local time: 10:26
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 24

Peer comments on this answer (and responses from the answerer)
neutral  Natalie: "General requirements for the modules" - это "Общие требования к модулям", а вовсе не "Справочник структурных элементов"
1 day 35 mins
  -> not reference book of the structural elements?
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8 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
reference book of the structural elements of a registration dossier of a medicinal product


Explanation:
On the classifier of types of documents for the registration dossier of a medicinal product and the reference book of structural elements of the registration dossier of a medicinal product
https://www.russiangost.com/C-8173-8173-general-documents-on...
https://www.russiangost.com/p-375698-decision-159.aspx

Frank Szmulowicz, Ph. D.
United States
Local time: 10:26
Works in field
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 282
Grading comment
Всем большое спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Oleg Lozinskiy
6 hrs
  -> Thank you, Oleg.

agree  Natalie
18 hrs
  -> Thank you, Natalie.

agree  svetlana cosquéric
21 hrs
  -> Thank you, svetlana.
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