The Pharmaceutical Industry Development Agency Ministry of Health of the Republic of Uzbekistan
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The State Pharmacopoeia is the main criterion for determining the quality of medicines and medical products

According to order No. 227 of the Ministry of Health dated August 28, 2020, the first volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan was approved.

The government of Uzbekistan pays special attention to the health of the population, and, of course, an important place in it is given to medicines. The rapid development of the domestic pharmaceutical industry is reflected in the increase in the number of pharmaceutical companies, the development and introduction of new original drugs, the improvement of the drug management system and the strengthening of quality control, etc.

The quality of medicines is checked in accordance with the established procedure and assessed for compliance with the requirements of approved standards, which is carried out in a complex sequence of processes for establishing and organizing production, storage, transportation and use of medicines in accordance with the established procedure.

The State Pharmacopoeia is a set of modern requirements for the quality of medicines and medical products, which, on the one hand, determines the level of development of the pharmaceutical industry in a particular country, and on the other, forms the basis for further improving the quality of medicines.

According to the World Health Organization, 56 national pharmacopoeias, as well as four regional and international pharmacopoeias registered to date. The existing pharmacopoeias differ in structure, the articles covered in them, requirements for standards, and the level of established norms.

From the above information, it is clear that today most countries do not have their own national pharmacopoeias, that is, the requirements and methods of quality control of medicines and medical products in circulation are limited by the adoption and application of the requirements of other countries.

This, in turn, can lead to the establishment of different quality criteria for the same product manufactured in different countries, the introduction into circulation of low quality products and other similar negative situations.

The work being carried out these days on development, approval and implementation of the State Pharmacopoeia of the Republic of Uzbekistan is another evidence of the special attention paid by the President to the pharmaceutical industry. It plays an important role in the introduction of medicines and medical products produced by local pharmaceutical companies, including new original pharmaceutical products created in the country, for use in international medical practice.

The basis for the publication of the State Pharmacopoeia of the Republic of Uzbekistan is reflected in the Law of the Republic of Uzbekistan dated January 5, 2016, No.399 ‘On medicines and pharmaceutical activities’, the 8th article of which states, ‘The State Pharmacopoeia is an official edition, which is a collection of documents containing requirements to medicines and medical products, general pharmacopoeial monographs, pharmacopoeial monographs and methods of quality control of medicines and medical products’.

According to the above, in accordance with the Decree of the President of the Republic of Uzbekistan dated April 10, 2019, No.5707 ‘On further measures for the accelerated development of the pharmaceutical industry of the republic 2019-2021’, the task was set to develop and approve the State Pharmacopoeia of Uzbekistan by September 2020. To ensure the fulfillment of this task, the Pharmaceutical Industry Development Agency signed an order No.24 on July 17, 2019 ‘On the organization of work and preparation for publication (re-edition) of the State Pharmacopoeia of the Republic of Uzbekistan’, and a number of necessary measures are being undertaken currently to fulfill the order.

The European Pharmacopoeia is a regional pharmacopoeia that maximally combines quality control methods for modern medicines and medical products. The European Pharmacopoeia is currently adopted in 38 countries, including those of the EU, and its main monographs are used in more than 100 countries.

Another notable aspect of the European Pharmacopoeia is that the World Health Organization has established the Pharmacopeial Discussion Group (PDG), which seeks to harmonize the pharmacopoeias of Europe, the United States and Japan. This, in turn, means that when developing the State Pharmacopoeia of the Republic of Uzbekistan, the European Pharmacopoeia is used as the main source and coordinated with it, which largely means that the pharmacopoeia of our country will be consistent with the pharmacopoeias of the United States and Japan.

Taking into account the current international requirements for the quality of pharmaceutical products, the Pharmaceutical Industry Development Agency together with the State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment, signed an agreement with the European Directorate for the Quality of Medicines and Healthcare (EDQM). According to this bilateral agreement signed on March 20, 2019, during the development and preparation for publication of the State Pharmacopoeia of the Republic of Uzbekistan, its texts to be coordinated with the 8-10 editions of the European Pharmacopoeia as the main source.

Also, according to a comparative analysis, 155 out of 157 general pharmacopoeial articles (monographs) included in the first volume of the first part of the Pharmacopoeia of the Eurasian Economic Union correspond to the texts of the State Pharmacopoeia of the Republic of Uzbekistan.

In addition, given the ongoing processes of globalization in the pharmaceutical industry, it is necessary to improve methods of quality control of medicines and medical products to facilitate the export of domestic pharmaceutical products to foreign markets. For this purpose, the texts of the main monographs included in the State Pharmacopoeia will be additionally brought into line with the leading pharmacopoeias - International Pharmacopoeia, United States Pharmacopoeia (USP), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP), Russian Pharmacopoeia (GF RF), Belarusian Pharmacopoeia (GF RB), Pharmacopoeia of Kazakhstan (GF RK), Pharmacopoeia of Ukraine (SFU) and others.

On the basis of 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 pharmacopoeial articles related to medicines and medical products used in veterinary practice.

When preparing the State Pharmacopoeia of the Republic of Uzbekistan, the recommendations of the World Health Organization ‘Necessary Pharmacopoeia Practice’ are taken into account. This, in turn, requires the development of standards of the Republic of Uzbekistan in accordance with the standards of the World Health Organization ‘Necessary Pharmacopoeial Practice’ at all stages of the development, preparation and assessment of regulatory documents on quality control of medicines produced by local pharmaceutical companies and imported into the country, and serves as the basis for application.

In pursuance of the Law of the Republic of Uzbekistan ‘On the state language’ (No. 167-I dated December 21, 1995) and the Decree of the President of the Republic of Uzbekistan No.5850 dated October 21, 2019 ‘On measures to radically increase the role and authority of the Uzbek language as the state language’, the first edition of the State Pharmacopoeia of the Republic of Uzbekistan gets developed in the state language.

In accordance with this order, from March 1, 2021, the Committee will ensure the fulfillment of the requirements of the State Pharmacopoeia of the Republic of Uzbekistan in the process of preparation, examination and approval of regulatory documents of domestic and foreign medicines and medical products submitted for state registration in the Republic of Uzbekistan. The task of harmonizing regulatory acts of domestic and foreign medicines and medical products that have passed state registration before March 1, 2021 with the State Pharmacopoeia of the Republic of Uzbekistan will be implemented until March 1, 2026.

Therefore, for the convenience of pharmacists, including foreign specialists working in the pharmaceutical market of Uzbekistan, and also taking into account the fact that the texts of the State Pharmacopoeia are used not only in laboratory, but also at all stages of drug circulation, we also found it appropriate to publish it in Russian.

The first volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan consists of 5 chapters, 40 sections and about 1200 pages of monograph texts in Uzbek and, accordingly, in Russian.

The first volume of the State Pharmacopoeia contains general methods of analysis, including physical, chemical, physicochemical, biological, pharmacognostic, pharmaceutical-technological, immunobiological and other research methods, as well as equipment, reagents, special solutions for research. This volume also includes general monographs on dosage forms, immunobiological, radiopharmaceutical preparations and related information.

In accordance with this order, the Pharmacopoeia Committee of the Republic of Uzbekistan will continue to develop the State Pharmacopoeia, prepare for publication, make specific changes and additions to it, and will also prepare for the approval of the second volume of the State Pharmacopoeia by December 31, 2021 and the third volume of the State Pharmacopoeia by December 31, 2022. The second volume of the State Pharmacopoeia will include private pharmacopoeial articles on dosage forms and substances, and the third volume will include private pharmacopoeial articles on medicinal plant raw materials, herbal preparations, as well as immunological, biological and radiopharmaceutical preparations.

In addition, the editors of the State Pharmacopoeia are entrusted with the tasks of regularly making additions and changes (amendments) to general and particular articles of the State Pharmacopoeia by analyzing changes and additions in the 10th edition of the European Pharmacopoeia, as well as in the pharmacopoeias of the Eurasian Economic Union, taking into account the internal conditions of the republic.

Articles (monographs) of the General Pharmacopoeia included in the first volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan are brought to the attention of interested organizations and institutions by posting them on the websites www.uzpharmagency.uz and www.uzpharm-control.uz in Uzbek (state) and Russian languages. The first volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan will be published in high-quality print in 500 copies.

In addition, special seminars will be organized for senior staff of organizations and institutions involved in research in the development of local medicines, organizations and institutions that manufacture medicines and medical products and control their quality.

Sardor Kariev, Director, the Pharmaceutical Industry Development Agency

Sherzod Abduganiev, Director, SUE ‘State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment’

Nodir Musaev, Chairman, the Pharmacopoeia Committee

Khabibulla Jalilov, Chief Editor, the State Pharma

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