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Harmonization and updating as basic principles of the development of the Republic of Kazakhstan state pharmacopoeia

Abstract

The second edition of the Republic of Kazakhstan State Pharmacopoeia (RKSP 2.0) is the practical implementation of the principles of continuous development, harmonization and updating. Features of RKSP harmonization with the leading pharmacopoeias of the world (European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia) determine the structure of its chapters and monographs, as well as used types and mechanisms of harmonization. The article reflects the changes made in general chapters and monographs of the Volume I of the RKSP 2.0 and which will be included in specific monographs of the Volume II of the RKSP 2.0.

About the Authors

S. R. Musinov
National center of expertise of medicines, medical devices and equipment of the Republic of Kazakhastan
Russian Federation


A. U. Tulegenova
National center of expertise of medicines, medical devices and equipment of the Republic of Kazakhastan
Russian Federation


References

1. State Pharmacopoeia of the Republic of Kazakhstan. V. I. Almaty: Zhibek Zholy; 2008 (in Russian).

2. State Pharmacopoeia of the Republic of Kazakhstan. V. II. Almaty: Zhibek Zholy; 2008 (in Russian).

3. State Pharmacopoeia of the Republic of Kazakhstan. V. III. Almaty: Zhibek Zholy; 2014 (in Russian).

4. State Pharmacopoeia of the Republic of Kazakhstan. 2nd ed. V. I. Almaty: Zhibek Zholy; 2015 (in Russian).

5. European Pharmacopoeia 8.0–8.8. Strasbourg: Council of Europe, EDQM.

6. British Pharmacopoeia 2016. London: The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).

7. U. S. Pharmacopeia. National Formulary USP 38—NF 33. Rockville: The United States Pharmacopeial Convention.

8. Standard Terminology: dosage forms, routes of administration into the body and containers. EDQM. Available from: www.edqm.eu.


Review

For citations:


Musinov S.R., Tulegenova A.U. Harmonization and updating as basic principles of the development of the Republic of Kazakhstan state pharmacopoeia. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(3):21-25. (In Russ.)

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ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)