GENERAL INFORMATION ABOUT THE PROCESS OF DEVELOPMENT OF THE STATE PHARMACOPOEIA OF THE REPUBLIC OF UZBEKISTAN
From the first edition's three volumes and appendix to the second: general and specific monographs in print and electronic form.
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State Pharmacopoeia 1st Edition Volume 1
Development of the State Pharmacopoeia of the Republic of Uzbekistan in accordance with the Decree of the President of the Republic of Uzbekistan dated April 10, 2019 "On measures for the more accelerated development of the pharmaceutical industry of the republic in 2019-2021"In accordance with paragraph 13 of Annex 1 of Decree No. UP-5707, it is established that:
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In addition, the principles of publication of the State Pharmacopoeia of the Republic of Uzbekistan are reflected in the Law of the Republic of Uzbekistan dated January 4, 2016 No. ZRU-399 "On Medicines and Pharmaceutical Activity", which according to the Paragraph 5 of Article 8 "The State Pharmacopoeia is published by the Ministry of Health of the Republic of Uzbekistan at least once every five years. Appendices to the State Pharmacopoeia will be published in the period between reprints of the State Pharmacopoeia."
In order to ensure the timely implementation of the above tasks and the effective organization of work, the order of the Minister of Health of March 5, 2019 No. 115 "On the organization of the working group of workers and experts on the formation of the State pharmacopoeia of the Republic of Uzbekistan" was signed in accordance with the Order of the Agency for the Development of the Pharmaceutical Industry of July 17, 2019The decree "On the organization of the work on development and preparation for publication (republication) of the State Pharmacopoeia of the Republic of Uzbekistan" was signed and the development of the State Pharmacopoeia of the Republic of Uzbekistan was started.
Taking into account modern international requirements for the quality of pharmaceutical products, the State Institution "Center for Safety of Pharmaceutical Products" and the European Administration for the Quality of Medicines and Medical Care of the European Union signed on March 20, 2019, according to the bilateral agreement signed on March 20, 2019, the State Pharmacopoeia of the Republic of Uzbekistan has been harmonized with the 8th-10th editions of the European Pharmacopoeia as the main source.
In addition, taking into account the international globalization processes in the pharmaceutical industry, attention is paid to the improvement of methods of quality control of medicines and medical products, in order to facilitate the export of domestic pharmaceutical products to foreign markets, the texts of major monographs included in the State Pharmacopoeia and to be introduced in the future, the attention is paid to the harmonization of the world's leading pharmacopoeias – international pharmacopoeia, US Pharmacopoeia (USP), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP), Russian Pharmacopoeia (GF RF), Belarusian Pharmacopoeia (GF RB), Kazakhstan Pharmacopoeia (GF RB), Pharmacopoeia of Kazakhstan (GF RK), Ukrainian Pharmacopoeia (DFU) and others.
Based on the relevant legislation of the Republic of Uzbekistan, it was decided not to include in the State Pharmacopoeia of the Republic of Uzbekistan the texts of pharmacopoeia articles related to medicines and medical products used in veterinary practice.
In the creation of the State Pharmacopoeia of the Republic of Uzbekistan, the guidelines of the World Health Organization "Necessary Pharmacopoeia Practice (GPhP)" are taken into account to the maximum. This, in turn, serves as the basis for the development and application of the standards of the Republic of Uzbekistan that comply with the World Health Organization standard "Necessary Pharmacopoeia Practice (GPhP)" at all stages of the development, preparation and evaluation of regulatory documents for quality control of medicines produced by local pharmaceutical enterprises and imported into the Republic.
In this process the State Pharmacopoeia of the Republic of Uzbekistan No. 167-I of December 21, 1995, as well as the Decree of the President of the Republic of Uzbekistan dated October 21, 2019 No. UP-5850 "On measures to radically increase the authority and status of the Uzbek language as the state language" The State Pharmacopoeia of the Republic of Uzbekistan 1st edition Volume 1 was developed in the state language.
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Ensuring the introduction of the requirements of the State Pharmacopoeia of the Republic of Uzbekistan into the processes of preparation, examination and approval of domestic and foreign medicines and medical devices submitted for state registration in the Republic of Uzbekistan from March 1, 2021, and the issue of compliance with the State Pharmacopoeia of domestic and foreign medicines and medical devices registered by March 1, 2021, in the process of their re-registration is determined to be carried out until March 1, 2026.
Therefore, for the convenience of specialists in the field of pharmaceuticals, including foreign specialists operating in the pharmaceutical market of Uzbekistan, taking into account the fact that the texts of the State Pharmacopoeia are used not only in laboratory analysis, but also at all stages of the circulation of medicines on a large scale, it was deemed appropriate to publish the State Pharmacopoeia in Russian at the same time, respectively.
Volume 1 of the State Pharmacopoeia 1st Edition contains general methods of analysis, including physical, chemical, physicochemical, biological, pharmacognostic, pharmacological, immunobiological and other research methods, equipment used in research, reagents, special solutions, etc. This volume also includes general pharmacopoeia articles on drug forms, immunobiological, radiopharmaceutical drugs, and related information.
In addition, the editorial board of the State Pharmacopoeia is entrusted with the task of gradually publishing the 10th edition of the European Pharmacopoeia on the basis of the ongoing changes and additions to it, as well as the gradual approval of the Pharmacopoeia of the Eurasian Economic Union, taking into account the internal conditions of the republic, and systematically making appropriate additions, amendments and additions to the texts of the State Pharmacopoeia of the Republic of Uzbekistan based on the results of the analysis.
The first edition of the State Pharmacopoeia of the Republic of Uzbekistan published articles (monographs) in the first volume on www.uzpharmagency.uz and www.uzpharm-control.uz websites and the first edition of the State Pharmacopoeia of the Republic of Uzbekistan in Uzbek (state) and Russian languages with 500 copies.
In addition, special seminars have been organized for the relevant employees of organizations and institutions carrying out research work on the creation of local medicines, organizations and institutions that produce medicines and medical devices and control their quality.
State Pharmacopoeia 1st Edition Volume 1 provides extensive coverage of general approaches to the assessment of the quality of medicines and related methods of analysis. Chapter I of this volume is devoted to general information and provides an overview of some rules, abbreviations pertaining to public and private pharmacopoeia articles, and an understanding of the International System of Measurements (SI) used in the State Pharmacopoeia and their other units of measurement. Chapter II covers various methods of analysis. In particular, physical and physicochemical methods, identification (chin) tests, boundary standard tests of mixtures, as well as quantitative analysis methods are described. This chapter also provides important information about biological testing and methods for determining biological activity. Chapter III discusses containers that are important for the storage and use of medicines and the materials used in their manufacture. Chapter IV focuses on the main reagents used in laboratory settings, buffer solutions, and titrated solutions, and shows methods to ensure the accuracy and reliability of analysis processes using standardized solutions. Chapter V summarizes general texts that meet pharmacopoeia requirements, which include recommendations for studying the functional properties of microbiological tests, biological preparations, methods of statistical analysis, residue of organic solvents and excipients. These sections serve to correctly interpret the articles in pharmacopoeia, to harmonize approaches to determining the quality of medicines, and to form a control system based on modern scientific and practical requirements.
Volume 2 of the 1st edition of the State Pharmacopoeia of the Republic of Uzbekistan
Decree of the Ministry of Health dated August 28, 2020 "On
approval of the State Pharmacopoeia of the Republic of Uzbekistan"GI
227-No. 11 specialized expert commissions of the Editorial Board of the State
Pharmacopoeia of the Republic of Uzbekistan, provided to a wide team of
specialists by the relevant departments of the Agency for the Development of
the Pharmaceutical Industry, including the Editorial Board of the State
Pharmacopoeia of the Republic of Uzbekistan Volume 2 of the State Pharmacopoeia of the Republic of Uzbekistan has
been developed.
Volume 2 of the 1st
edition of the State Pharmacopoeia contains about 30 general pharmacopoeia
articles describing the main types of drugs widely used in practice today. The
main part of this volume contains a total of 10699 state-registered articles
that are currently allowed for use in medical practice in the Republic of
Uzbekistan, including 3130 synthetic substances of drugs produced by local
pharmaceutical enterprises and 7569 synthetic substances of mainly drugs
produced by foreign pharmaceutical enterprises, as well as private
pharmacopoeia articles of certain excipients widely used in their production.
Articles included in Volume 2 of the State Pharmacopoeia "State register of medicines, medical devices and medical
equipment approved for use in medical practice in the Republic of
Uzbekistan"
Based on the 25th edition (2021).
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This approach in the compilation of the state pharmacopoeia allows, if necessary, to control the finished medicines in circulation in the Republic, substances and excipients used in their manufacture, as well as individual medical products, to control their composition, if necessary, alien and related substances and other mixtures.
The first volume of the first edition of the State Pharmacopoeia probably includes sections on methods of general analysis, including physical, chemical, physico-chemical, biological, pharmacognostistic, pharmaceutical-technological, immunobiological, statistical processing of analysis results and other research methods, such sections as equipment, reagents, special solutions used in research.
Volume 2 of the State Pharmacopoeia contains separate general pharmacopoeia articles, general articles on drug forms, and private pharmacopoeia articles of drug substances.
Volume 3 of the 1st edition of the State Pharmacopoeia of the Republic of Uzbekistan
In accordance with
the Decree of the President of the Republic of Uzbekistan dated April 10, 2019
"On measures for the more accelerated development of the pharmaceutical
industry of the republic in 2019-2021"Decree No. UP-5707 establishes
the task of developing the State pharmacopoeia in a short time in harmony with
the pharmacopoeia of international, regional and developed countries,
recognized in the world, is an expression of high attention to the further
development of various directions of the pharmaceutical industry in the
country, as well as a special demand and responsibility.
Formulation of modern high requirements for finished medicines and the use of active and excipients and other raw materials used in their production is aimed at ensuring the most important issue in the final analysis, namely ensuring the highest quality, effectiveness and harmlessness of medicinal products.
On February 07, 2023, by Order of the Minister of Health of the Republic of Uzbekistan No. 26 "On approval of the State Pharmacopoeia of the Republic of Uzbekistan", the third volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan was approved and published by the State Institution "Center for the Safety of Pharmaceutical Products" and presented to specialists in books and electronic form.
The first edition of State Pharmacopoeia Volume 3 consists of two parts, totaling 2,100 pages. This 3rd volume is a logical continuation of the first (2020) and second (2021) volumes published in previous years.
Volume 3 of the 1st edition of the State Pharmacopoeia includes a total of 541 private pharmacopoeia articles of medicinal herbal raw materials and medicines made from medicinal plant raw materials; homeopathic preparations; vaccines for use in medicine; immune serums for use in medicine; biotherapeutic products for use in medicine; radiopharmaceutical preparations and medicines belonging to the groups of raw materials for use in medicine. At the same time, the General pharmacopoeia articles section also contains a total of 17 general pharmacopoeia articles of drugs related to the above groups.
European pharmacopoeia was used as the main source for the preparation of the draft state pharmacopoeia in the harmonize with internationally recognized pharmacopoeiia, and as auxiliary sources, depending on their priority, international and EU pharmacopoeiia, pharmacopoeias of the USA, Britain, Japan, as well as those of the Republic of Belarus, the Russian Federation, the Republic of Ukraine, the Republic of Kazakhstan, etc.
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In order to ensure the implementation of the state pharmacopoeia the decree establishes the tasks of the relevant relevant departments, as well as the corresponding employees of enterprises of the domestic pharmaceutical industry and foreign companies operating in the pharmaceutical market of Uzbekistan.
The first edition of the State Pharmacopoeia approved and gradually introduced in accordance with the relevant orders of the Ministry of Health was published in books and electronic forms in Uzbek and Russian on 7236 pages consisting of 3 volumes. The creation of the State Pharmacopoeia was an expression of the great hard work of about 200 members of the Editorial Council and the Editorial Board consisting of high-level specialists, as well as the agreement concluded with the European Directorate for Health and Drug Quality (EDQM) in 2019, on the other hand, in accordance with the system established for the development of the State Pharmacopoeia of 11 specialized expert commissions and their working groups, as well as members of the Editorial Board and the Editorial Jury, consisting of high-level specialists.
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Volume 3 of the 1st edition of the State Pharmacopoeia covers general pharmacopoeia articles on various medicines and products used for medical purposes. This volume outlines articles, in particular, related to the evaluation of medicinal plant raw materials, medicines made from them, homeopathic preparations, as well as vaccines, immune serums, biotherapeutic products, and radiopharmaceutical preparations. In addition, pharmacopoeia requirements and technical norms for standardization of products important for medical needs, such as sedative materials, are given.
The articles presented in this volume are an important resource in the analysis of medicines based on natural and biological sources, their quality assessment, and ensuring their medical safety. They serve as scientific, theoretical and practical guidelines for practicing professionals.
Appendix to the State Pharmacopoeia 1st Edition Volume 1
The inclusion of the Republic of Uzbekistan in the European Pharmacopoeia Commission as an observer on the preparation of the State Pharmacopoeia for publication (republication) According to the Decision of the 163rd session of the European Pharmacopoeia Commission dated March 20, 2019, the Agreement "On granting the right of adaptation and harmonization of the texts of the European Pharmacopoeia in the creation of the State Pharmacopoeia of the Republic of Uzbekistan" became especially noteworthy.
Another noteworthy aspect of the development of the National State Pharmacopoeia is that the right to use the requirements of the U.S. Pharmacopoeia was granted by its patent holder, the U.S. Pharmacopoeia Convention, pursuant to the "Granting Rights to Adopt the United States Pharmacopoeia – National Formula" signed on May 12, 2023, between the U.S. Pharmacopoeia Convention and the Department of Health of the Republic of Uzbekistan, as well as the "Memorandum of Understanding" signed on August 8, 2023.
Within the scope of
the above-mentioned agreements, the Editorial Board approved the 1st Edition of
the European Pharmacopoeia in effect today 11th and the USP of the US
Pharmacopoeia 2024
(USP-47 NF-42) Published in 1994.
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Since the Appendices of the State Pharmacopoeia of the Republic of Uzbekistan (hereinafter referred to as the Appendices of the State Pharmacopoeia of the Republic of Uzbekistan) are based on the principles and approaches of European and U.S. Pharmacopoeia, the Appendices of the State Pharmacopoeia provide for the presentation of the materials in a publication as close as possible to the European and U.S. Pharmacopoeia. The numbering of monograph sections and titles, chemical names of substances, names of reagents, units of measurement of physical quantities, computational formulas, etc., are almost identical to those given in the Pharmacopoeia.
The main principle of the publication is the harmonization of national pharmacopoeia standards with the world's leading pharmacopoeia. If the previous volumes of the State Pharmacopoeia of the Republic of Uzbekistan contain rules and requirements harmonized with the European pharmacopoeia, the current edition is also harmonized with the standards of the US Pharmacopoeia
According to the results of the analysis, a total of 51 general pharmacopoeia articles, according to their content, were deemed expedient to include in Volume 1 of the State Pharmacopoeia and some changes and additions to about 100 general pharmacopoeia articles.
In accordance with the established procedure of record-keeping, general pharmacopoeia articles on selected topics were processed and examined by specialized expert commissions on the relevance of the topics, taking into account local conditions in accordance with the requirements of national legislation, and presented for public discussion by posting on open sites.
The 31 general pharmacopoeia articles included in the annexes to Volume 1 of the 1st edition of this submitted State Pharmacopoeia are aligned with USP 2024 (USP- 47 NF-42) and 20 general pharmacopoeia articles are harmonized with the 11th edition of the European Pharmacopoeia.
The appendix to Volume 1 of the 1st Edition of the State Pharmacopoeia contains technical descriptions of the equipment used in the analysis of drugs and guidelines for their use. It also describes in detail physical and physicochemical methods, limited quantity testing of compounds, quantitative determination methods, and methods for determining biological activity.
In addition, this appendix contains pharmacognostic methods, pharmaceutical-technological trials, general texts on microbiology, general texts on biological preparations, standard samples, and important information and technical recommendations on chemical imaging.