THE ROLE OF THE SCIENTIFIC OVERVIEWS IN THE GENERIC DRUG REGISTRATION PROCESS IN THE RUSSIAN FEDERATION AND EURASIAN ECONOMIC UNION
Abstract
Background: Non-clinical and clinical overviews are an obligatory part of the Common Technical Document, that is the new format of the registration dossier in the Russian Federation and Eurasian Economic Union. Development of the overview demands on specific skills of the literature search and critical appraisal and also of systematization of scientific data. Goal of the paper consists of the description of the latest legislative rules about the development of the reviews for generic drug application by Russian national and EAEU rules and also practical experience of SMA LitReview. Conclusions: The review is one of the key elements of the generic drug dossier now in the Russian Federation and EAEU. In some cases, the review can replace the results of own trials of the Sponsor. Review process demands skills of the use of the international bibliographic databases, critical appraisal, good academic writing skills and also knowledge of modern Russian and EAEU law.
About the Author
K. S. Milchakov
Scientific medical journal organization «Litobzor»
Russian Federation
Russian Federation
References
1. Bordens K., Abbott B. Reviewing the Scientific Literature // Research Designs and Methods. 2004. C. 63-94.
2. Pollock A., Berge E. How to do a systematic review // International Journal of Stroke. 2017. Т. 13. № 2. C. 138-156.
3. On circulation of medicines. Federal law № 61 of 12 April 2010.: ed. 04.06.2018. Available at: http://www.consultant.ru/document/cons_doc_LAW_99350/( accessed 22.08.2018).
4. On amendments to the Federal law on circulation of medicines. Federal law № 429 of 22 December 2014.: ed. 22.12.2014. Available at: http://www.consultant.ru/document/cons_doc_LAW_172505/ (accessed 22.08.2018).
5. GOST R 7.0.11-2011. Dissertation and dissertation abstract. The structure and rules of registration // Moscow: ROSSTANDART. Updated: June 16, 2015. Available at: http://gost.ru (accessed 24.08.2018).
6. GOST R 7.32-2001 Report on research work. The structure and rules of registration // Moscow: ROSSTANDART. Updated: June 16, 2015. Available at: http://gost.ru (accessed 24.08.2018)
7. On the Rules of registration and examination of medicines for medical use. Decision of the Council of the Eurasian economic Commission № 78 dated 03.11.2016. Available at: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78 (accessed 22.08.2018).
8. DACENTA. A review of organisational and patient-related assessments in HTAs published by INAHTA members / Danish Centre for Health Technology Assessment.-National Board of Health: 2007. С. 131.
9. On the Requirements for electronic form of statements and documents of the registration dossier provided during the registration and examination of medicinal products for medical applications. The decision of the Council of the Eurasian economic Commission № 79 from 30.06.2017. Available at: https://www.garant.ru/products/ipo/prime/doc/71611336/ (accessed 22.08.2018).
10. Rozhdestvenskij D. A. Ghost dossier of a medicinal product in accordance with the requirements of the EEC. Available at: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LS1/Documents/Рождественский%20АдамСмит%202017.pdf (accessed 22.08.2018 г.)
11. Guidelines for the examination of medicines. V. I - M.: Fretboard. 2014. P. 328.
12. Cooke A, Smith D, Booth A. Beyond PICO. / 1Cooke A, Smith D, Booth A. Beyond // Qual Health Res. 2012. Т.22. № 10. C.1435-1443.
13. Shea B. J., Hamel C., Wells G. A., Bouter L. M. et al. AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews./ J Clin Epidemiol. 2009. T. 62. № 10. С. 1013-1020.
Review
For citations:
Milchakov K.S. THE ROLE OF THE SCIENTIFIC OVERVIEWS IN THE GENERIC DRUG REGISTRATION PROCESS IN THE RUSSIAN FEDERATION AND EURASIAN ECONOMIC UNION. Drug development & registration. 2018;(4):99-105. (In Russ.)
Views:
1131
Email this article 