Medical Writing Preclinical Studies Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards
cover-imagepng

Volume 26, Issue 4 - Preclinical Studies

Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards

Abstract

Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental data to domestic legislation. In this article, we discuss the main regulatory documents in Russia, their compliance with international standards (Good Laboratory Practice), the structure of the responsible authorities, and problems with implementing the regulatory documents. Finally, we discuss the current regulatory trends in Russian nonclinical studies.
Download the full article

References

  1. Russian Federation Federal Law no. 61-FZ “On Circulation of Medicines” dated April 12, 2010. Available from: https://www.unodc.org/res/cld/ document/rus/federal-law-on-circulationof- medicines_ html/Russian_Federation_ Federal_Law_On_ Circulation_of_ Medicines_61-FZvEN.pdf
  2. Decree no. 2603-r dated December 28, 2012 [cited October 13, 2017]. Available from: http://docs. cntd.ru/document/ 902392511
  3. Decision no. 2067-r dated November 8, 2013 [cited October 13, 2017]. Available from: http://docs.cntd.ru/document/ 499056249
  4. Decision no. 1172 dated December 17, 2013 [cited October 13, 2017]. Available from: http://docs.cntd.ru/document/ 499065307
  5. Decree of the Ministry of Industry and Trade of the Russian Federation no. 965 dated October 23, 2009 [cited October 13, 2017]. Available from: http://docs.cntd.ru/ document/902186334
  6. “Guidelines for the Testing of Chemicals”, 2014 [cited October 13, 2017]. Available from: http://docs.cntd.ru/search/ intellectual/q/Методы+испытания+по+ воздействию+химической+продукции+ на+организм+человека/r/1
  7. Decree no. 199 n “On approval of the principles of Good Laboratory Practice” dated April 1, 2016 [cited October 13, 2017]. Available from: http://docs.cntd.ru/ document/420350679
  8. National standard of the Russian Federation GOST R 53434-2009 “The principles of Good Laboratory Practice” dated April 1, 2016 [cited October 13, 2017]. Available from: http://docs.cntd.ru/ document/1200075972
  9. Mironov AN, editor. Guidelines for Preclinical Trials of Medicinal Products. Part 1. Moscow: Grif i K; 2012. Available from: http://
  10. Mironov AN, editor. Guidelines for Preclinical Trials of Medicinal Products. Part 2. Moscow: Grif i K; 2012. Available from: http://
  11. Federal Law “On amendment of the Federal Law ‘On Circulation ofMedicines’” no. 429-FZ dated December 22, 2014 [cited October 13, 2017]. Available from: http://pravo.gov.ru/proxy/ips/?docbody= &firstDoc=1&lastDoc=1&nd=102364596
  12. Litchfield JT, Wilcoxon F. A simplified method of evaluating dose-effect experiments,J Pharmacol Exp Ther. 1949;96(2):99–113. Available from: http://
  13. Lim RK, Rink KG, Glass HG Soaje- Echague E. A method for the evaluation of cumulation and tolerance by the determination of acute and subchronic median effective doses. Arch Intern Pharmacodyn. 1961;130:336 –53. Available from: http://
  14. Guidance on expert assessment of the medicinal products. V. 1-4; 2013-2014. Available from: http://fptl.ru/ biblioteka/razrabotka-i-ekspertizalekarstv. html
  15. GOST 33647-2015 “Principles of good laboratory practice (GLP). Terms and definitions”, 2015 [cited October 13, 2017]. Available from: http://docs.cntd.ru/ document/1200129061

Search

Articles

Preclinical studies
President’s Message
EMWA celebrates 25 years
EMWA News
Preclinical research in drug development
An introduction to little-known aspects of nonclinical regulatory writing
Reporting of preclinical research: What do we get told – when and how?
Mind the gap – towards complete and transparent reporting of animal research
The reproducibility crisis in preclinical research – lessons to learn from clinical research
Nonclinical studies in the Russian Federation — Problems, regulatory norms, and harmonisation with international standards
How to survive Brexit as an independent medical writer
Creation of a patient-centric patient lay summary in the local language
Six communication rules for scientific presentations and writing
So, you want to be a medical journalist?
News from the EMA
Profile: An interview with Steven Walker
Getting Your Foot in the Door
In the Bookstores
Journal Watch
The Webscout
Good Writing Practice
Medical Communications
Out on Our Own

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: