INSTRUCTIONS ON THE STRUCTURE AND APPLICATION OF THE STATE PHARMACOPOEIA OF THE REPUBLIC OF UZBEKISTAN

According to the Decree of the President of the Republic of Uzbekistan dated October 29, 2020 No. PD-6097 "On approval of the concept of development of science until 2030", the tasks of accelerated development of economic sectors and social sphere in the Republic of the country, the widespread use of scientific and innovative potential with full mobilization of scientific, intellectual and financial resources, in the future determination of priority areas of systematic reform of science and their implementation are outlined.

In the development of the local pharmaceutical industry, it is important to introduce the achievements of modern science in various areas of the industry. In this regard, the scientists of our country engaged in scientific activities in the field of pharmaceuticals are faced with such important tasks as the creation of new original medicines intended for the treatment of diseases common among the population and the improvement of technologies of certain medicines, as well as the creation of new analogues in order to increase their effectiveness, safety and quality.

In particular, today a number of original and new complex medicines have been developed and allowed for use in medical practice by the scientists of our republic in the creation of effective medicines. The development of pharmacopoeia articles that ensure standardization of these new drugs at the level of international requirements and their inclusion in the State Pharmacopoeia will provide an opportunity to obtain permits for the use and export of high-efficiency, harmless medicines created by scientists of Uzbekistan in medical practice abroad.

It is also extremely important to ensure the quality, efficacy and safety of medicines. The quality of medicines is examined in accordance with the established procedure and evaluated for compliance with the requirements of approved standards, and it is implemented in the processes of creation, organization of production, storage, transportation and application of medicines in the prescribed way.

According to the Decree of the President of the Republic of Uzbekistan dated January 23, 2024 No . UP-20 " On additional measures for the regulation of the pharmaceutical sector" it is planned to develop separate rules for the implementation of state control by organizations responsible for ensuring guarantees of quality, safety and effectiveness of medicines and medical devices at various stages. It implies that the implementation of state quality control of medicines is based on the level of quality standards created at the level of modern international requirements, in particular the requirements of the State Pharmacopoeia of the Republic of Uzbekistan (hereinafter referred to as the State Pharmacopoeia of the Republic of Uzbekistan).

Pharmaceuticals and medical supplies put into quality indicators

The set of requirements is reflected in the State Pharmacopoeia. This makes it urgent to regularly develop, improve and implement the State Pharmacopoeia in cooperation with experts in the relevant field on the basis of modern scientific achievements.

The competence of the Ministry of Health includes carrying out work on quality control and standardization of medicines and medical products, as well as the organization of approval and publication of the state pharmacopoeia

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Implementing the Decree of the President of the Republic of Uzbekistan dated April 10, 2019 No. UP-5707 "On measures for further accelerated development of the pharmaceutical industry of the republic in 2019-2021", an official system has been created, consisting of the Editorial Board and Council, 11 specialized expert commissions and their working groups, and its The 1st edition of the State Pharmacopoeia of the Republic of Uzbekistan for 2020-2023 has been fully developed and presented in books and electronic forms to legal entities and individuals who use it in their practice.

The inclusion of the Republic of Uzbekistan in the European Pharmacopoeia Commission as an observer in the preparation of the State Pharmacopoeia for publication (re-publication) According to the Decision of the 163rd session of the European Pharmacopoeia Commission dated March 20, 2019, the Agreement "On providing 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.

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.

Undoubtedly, the standardization of products of the domestic pharmaceutical industry at the level of modern international requirements demonstrates the important role of the State pharmacopoeia in the production of import-substituting and export-oriented medicines due to their further improvement of quality.

One of the main directions of the principles of the development of the state pharmacopoeia is determined by its systematic supplementation and improvement in the light of the latest achievements of science.

Indeed, on the basis of the globalization of today’s scientific progress at the international level, it can be observed that in the production of pharmaceutical products, the regulatory framework of international quality standards aimed at ensuring their quality is at the level of high requirements, it can be observed that the regulatory framework is rapidly developing, improving such indicators as the specificity, sensitivity and reproducibility of quality control methods of products.

In the process of developing the 1st edition of the State Pharmacopoeia, its monographs were coordinated with the world’s leading pharmacopoeia, in which the relevant publications of the European Pharmacopoeia were used as the main source, in particular the 8th-9th editions in the development of the 1st volume, the 9th in the development of the 2nd volume and the 9-10th in the development of the 3rd volume.

In the process of gradually developing the state pharmacopoeia over a period of more than 5 years, separate additions and amendments were made to a number of international and world mature pharmacopoeias, including the European Pharmacopoeia. In particular, since the 9th edition of the European Pharmacopoeia in practice today

Between their 11th editions, a total of 30 new pharmacopoeia articles were introduced, 3 obsolete pharmacopoeia articles were omitted, and the texts of 131 pharmacopoeia monographs were supplemented and amended to varying degrees.

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.

On the scale of the above-mentioned agreements, the 1st edition of the State Pharmacopoeia was reviewed by the Editorial Board in conjunction with the current 11th edition of the European Pharmacopoeia and the USP 2024 (USP-47 NF-42) editions of the US Pharmacopoeia in force.

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Harmonization of pharmacopoeia standards is one of the most complex types of global pharmacopoeia activities. It can be carried out using retrospective and perspectiveal, complete and selective (partial) mechanisms. Retrospective harmonization is carried out for chapters and monographs included in pharmacopoeia. For drugs that were not previously the subject of pharmacopoeia standardization, and for methods of testing them, the perspective type can be applied. Perspective harmonization is much lighter than retrospective harmonization. A full harmonization mechanism ensures complete mastery of texts without taking into account any changes. The selective mechanism allows you to absorb selected parts, taking into account justified and agreed changes.

Only some letter designations of physical magnitudes in computational formulas have changed due to the traditional use of normative documents. For the same reasons, the scope of abbreviations and abbreviations used in the State Pharmacopoeia has been expanded.

Harmonization determines the availability of labeling of pharmacopoeia texts. Labeling allows texts from the world’s leading pharmacopoeia to be distinguished from the State’s own national pharmacopoeia texts.

Texts from U.S. pharmacopoeia are designated with the special symbol "USP," respectively.

The standard samples of the world’s leading pharmacopoeia and their own (national) standard samples are accepted as standard samples of active substances and mixtures of the State pharmacopoeia are adopted.

In executing a pharmacopoeia method, the executor should evaluate (verify) whether the method is appropriate for the actual conditions of use and how appropriate it is to confirm its compliance with the requirements of private and general pharmacopoeia articles, as well as quality systems. Assessment of the adequacy of the pharmacopoeia method and the degree of its suitability Verification of pharmacopoeia methodologies should be carried out in accordance with the requirements of the general pharmacopoeia article.

The implementation of these quality standards in the local pharmaceutical industry is another important step towards guaranteeing the quality of local pharmaceutical products.

Indeed, the national implementation of the "State Pharmacopoeia" prepared for publication in combination with regional or national pharmacopoeia of developed countries imposes extremely important tasks for all economic entities operating in the field of pharmaceuticals, especially for product manufacturers.

In the development of the texts of pharmacopoeia articles, the lexical and grammatical possibilities of the Uzbek and Russian languages were fully used. At the same time, it was established that the current edition of European and/or US pharmacopoeia should be the basis in order to avoid different interpretations of the texts of monographs in case of doubts or disagreements among users regarding the specific phrases and definitions used.

The methods of testing and quantitative analysis given in pharmacopoeia are formal methods, but in consultation with the competent authority, other alternative methods may be used, which will yield results consistent with the methods of pharmacopoeia. In the event of doubt or disagreement, the method of pharmacopoeia will be of decisive importance.

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 first priority level rightly belongs to the DF of the Republic of Uzbekistan as the main quality standard for medicines in the country. In the absence of a corresponding monograph in the national pharmacopoeia, the European pharmacopoeia (second priority level) applies, and in the absence of the European Pharmacopoeia, the requirements of the US pharmacopoeia (third priority level) come into force.

The gradual introduction of the state pharmacopoeia plays an important role in raising the quality of medicines and medical products produced in the Republic by local enterprises, as well as imported in our country as finished products at the level of international requirements, in particular the requirements of standards of developed countries of the USA and Europe.

The texts of the state pharmacopoeia are used not only in laboratory analysis, but also in the process of all stages that constitute the circulation of medicines on a large scale: their creation, preclinical and clinical studies, the organization of production, storage, standardization and certification, as well as the implementation of quality control of pharmaceutical products in the processes of sale, distribution and application, as well as in the process of education. Also, the set of documents submitted for state registration of medicines and medical products in order to enter the pharmaceutical market of Uzbekistan must comply with the requirements of the national pharmacopoeia.

It is worth noting that the national GMP standard according to "Good Manufacturing Practice", approved by the state standard DSt 2766:2018, is based on the Guidelines "Pharmaceutical Quality System" (ICH Q10) of the International Conference on Harmonization, as well as a number of requirements according to its own DSt 2766:2018 "European Rharmasoroeia. 6th Edition. European Directorate for the Quality of Medicines (EDQM). - Council of Europe, 67075 Strasbourg Cedex, Franse 2007. -3308 R."

Also, according to the state standard DSt 2764:2018, the quality assurance system of medicines is carried out by organizations engaged in wholesale pharmaceutical activities in the country in accordance with the State Pharmacopoeia and the specifications developed on its basis.

In addition, the set of documents submitted for state registration of medicines and medical devices in order to enter the pharmaceutical market of Uzbekistan must comply with the requirements of national pharmacopoeia standards.

The orders of the Minister of Health states:

"Ensuring the introduction of the requirements of the State Pharmacopoeia of the Republic of Uzbekistan into the processes of preparation, examination and approval of regulatory documents of domestic and foreign medicines and medical devices submitted for state registration in the Republic of Uzbekistan;

Implementation of the issue of harmonization of state-registered domestic and foreign medicines and medical devices with the State Pharmacopoeia of the Republic of Uzbekistan, in the process of their re-registration;

the tasks of gradually complying with the requirements of the standard "Necessary pharmacopoeia practice – GPhP" recommended by WHO in the process of preparation, examination and approval of regulatory documents submitted for state registration of medicines and medical devices.

In the creation of the state pharmacopoeia, 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 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 the process of developing these volumes, it should be noted that the general pharmacopoeia articles, pharmacopoeia articles, separate texts and information are developed primarily on the basis of the legislation of the Republic of Uzbekistan, and at the same time their harmonization with the European pharmacopoeia is carried out.

The Pharmacopoeia body of the country is a full member of the U.S. Pharmacopoeia Convention, the European Directorate for Health and Drug Quality of the European Community (EDQM) and the EU Pharmacopoeia Committee as observers are actively engaged in the development of monographs of leading pharmacopoeias of developed countries, as well as in the creation of the State Pharmacopoeia of the Republic of Uzbekistan.

In general, ensuring the implementation of the requirements of the State pharmacopoeia is the main factor in guaranteeing the provision of the population of our country with high-quality, high-effectiveness harmless drugs.

Taking into account the above, the development of new monographs to be included in the State Pharmacopoeia, preparation for publication, as well as the introduction of appropriate additions, additions and amendments to the texts in the intervals of publications, if necessary, are regularly carried out in order to make it easier for specialists. In this regard, all proposals and comments submitted to the Editorial Board of the State Pharmacopoeia of the Republic of Uzbekistan are carefully studied.