pharmaceutical regulation
Russian Laws

National Standard GOST R 57679-2017 of Russia
"Bioequivalence Study of Medicinal Products"

The legal document below was translated into Russian by CEG or a translation company on behalf of CEG.
This translation may contain inaccuracies. For all issues related to law enforcement practice, please contact the authorities of Russia / the EAEU and CEG company. This is unofficial translation in English of the valid official document.
FEDERAL AGENCY FOR TECHNICAL REGULATION AND METROLOGY

NATIONAL STANDARD OF THE RUSSIAN FEDERATION
GOST R 57679-2017

MEDICINAL PRODUCTS FOR HUMAN USE

Bioequivalence Study
of Medicinal Products

(DDT CPMP/EWP/QWP/1401/98. version 1, NEQ)
2017
Introduction

1 DEVELOPED by State Budget Education Establishment of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation (I.M. Sechenov First MSMU).

2 SUBMITTED by the Standardization Technical Committee 458 "Development, Manufacturing, and Quality Control of Medicinal Products".

3 APPROVED AND ENACTED by Order of the Federal Agency for Technical Regulation and Metrology dated September 19, 2017 under No. 1165-st.

4 This standard is developed with consideration of the regulatory provisions of the Guideline of the European Medicines Agency CPMP/EWP/QWP/1401/98. Edition 1 "Bioequivalence Study of Medicinal Products for Human Use" (CPMP/EWP/QWP/1401/98 Rev. 1 "Guideline on the investigation of bioequivalence", NEQ).

5 INTRODUCED FOR THE FIRST TIME.

The rules for application of this standard are stipulated by Article 26 of Federal Law No. 162-FZ dated June 29, 2015 "On Standardization in the Russian Federation". Information on amendments to this standard is posted in the annual (as of January 1 of the current year) information index "National Standards", while the official test of amendment and changes — in the monthly information index "National Standards". In case of revision (replacement) or cancellation of this standard, the respective notice will be published in the next issue of the monthly information index "National Standards". The respective information, notices, and texts are also posted in the public information system, i.e. on the official website of the Federal Agency for Technical Regulation and Metrology (wwww.gost.ru).
Leave Your Contact Details in the form below.
We'll contact you within a day.