INTERNATIONAL COOPERATION IN THE DEVELOPMENT OF THE STATE PHARMACOPOEIA OF THE REPUBLIC OF UZBEKISTAN

The State Pharmacopoeia of the Republic of Uzbekistan works in the direction of integration and cooperation with the world's leading pharmacopoeias, international organizations and regulatory bodies. This process is aimed at ensuring the quality, safety and effectiveness of medicines in accordance with international standards.

The State Pharmacopoeia of the Republic of Uzbekistan, in cooperation with international pharmacopoeia bodies, plays an important role in improving national standards and ensuring the quality of medicines. The harmonization process serves to apply the best international practices in the field of pharmaceuticals and ensure the recognition of medicines produced in Uzbekistan in the world market.

The State pharmacopoeia of the Republic of Uzbekistan has established relations with over 10 international organizations and pharmaceutical bodies, including:

International Pharmacopoeia of the World Health Organization (WHO) and International Meeting of World Pharmacopoeias (IMWP);
European Directorate for Medicines Quality and Health (EDQM);
European Pharmacopoeia (Ph.Eur.);
European Medicines Agency (EMA);
U.S. Pharmacopoeia Convention (USP);
Pharmacopoeia Committee of the Eurasian Economic Union (EEU);
International Council for Harmonization of Technical Requirements for Human Pharmaceuticals (IC);
International Platform for Drug Regulatory Regulation (IPRP);
Organization of Turkic States (OTS) – Pharmacopoeia of Turkic States, etc.

Cooperation with World Health Organization (WHO)

To date , a total of 57 regional and national pharmacopoeias have been recognized by WHO, and the Index of World Pharmacopoeias and Pharmacopoeiial Authorities by World Health Organization is included in the Index of World Pharmacopoeias and Pharmacopoeiial Authorities. Including the State Pharmacopoeia and Pharmacopoeia Authority of the Republic of Uzbekistan has been occupying a worthy place from this index since December 2021.

Cooperation with the European Directorate for Health and Drug Quality (EDQM)

Based on the decision of the European Pharmacopoeia Commission regarding the preparation of the national pharmacopoeia for publication The Republic of Uzbekistan was included in the European Pharmacopoeia Commission as an observer, The European Pharmacopoeia Commission As of March 20, 2019
163-session decision between the State Institution "Center for Safety of Pharmaceutical Products" and the European Pharmacopoeia Commission "On the provision of the right to harmonize and copy the texts of the European Pharmacopoeia in the creation of the State Pharmacopoeia of the Republic of Uzbekistan"An agreement has been signed.

Partnership with U.S. Pharmacopoeia

On May 3, 2023 "Granting Rights to Adopt the United States Pharmacopoeia – National Formula" An important agreement was signed. This laid the groundwork for updating the pharmacopoeia of Uzbekistan in accordance with international standards. Later,
2023-September 8, 2018 in order to further strengthen cooperation in this direction. Memorandum of Understanding signed.

According to the relevant clauses of the agreement and the memorandum, it is stated that:

the provision of rights for use in the forms of harmonization, coordination and copying of articles USP-NF, which are the intellectual property of the US Pharmacopoeia Convention, in the process of development and processing of the state pharmacopoeia;
To use the standards and data periodically during the development and revision of the State Pharmacopoeia through the gradual harmonization and coordination of the standards and information newly introduced into the USP-NF or as a result of the revision;
ensure that they comply with the requirements of USP-NF during the development and revision of separate pharmacopoeia articles and monographs during the development and revision of the state pharmacopoeia;
It should also be noted that the state pharmacopoeia articles also apply the requirement to use USP reference standards regarding active and excipient substances, providing for the use of pharmacopoeia standard samples.

Along with the above, in accordance with the agreement, ample opportunities will be created for the implementation of the following activities:

advanced training of specialists of the State Institution "Center for Safety of Pharmaceutical Products";
provide free online access to the current version of USP-NF and purchase standard samples at discounted prices;
organization and joint participation in various international events in the field of standardization and quality control of medicines.

Cooperation with the Pharmacopoeia Committee of the Eurasian Economic Union (EU)

By the Resolution No. 14 of the Supreme Economic Council of the Eurasian Economic Council dated December 11, 2020 "On the accession of the Republic of Uzbekistan to the Eurasian Economic Union under the status of an observer state", in accordance with Article 109 of the Treaty on the Eurasian Economic Union signed on May 29, 2014, the Republic of Uzbekistan was granted the status of an observer state of the Eurasian Economic Union (EEU). In this regard, it will be necessary to harmonize with the EU Member States the issues of standardization and technical regulation in the field of pharmaceuticals.

Of particular importance is the inclusion of representatives of the Pharmacopoeia body of Uzbekistan as observers in the Pharmacopoeia Committee of the Republic of Uzbekistan.

This in turn, provides an opportunity to participate in sessions on the development of the EUOII pharmacopoeia and to get acquainted with the results of relevant scientific research, participate in their discussion and use them.

Cooperation with Organization of Turkic States

On August 16, 2023, an important document within the framework of the Organization of Turkic States was adopted - a Declaration of Cooperation aimed at establishing a group for the development of a pharmacopoeia of Turkic States. This declaration serves as a basis for further strengthening ties in the field of pharmaceuticals between the Turkic states and the creation of uniform standards.

On July 1, 2024, the 1st meeting of the working group on the development of Turkish pharmacopoeia of the Organization of Turkic States was held. At the meeting, the Editor-in-Chief of the State Pharmacopoeia of the Republic of Uzbekistan Professor Kh.K.Dzhalilov made a presentation on the topic "Topical issues of development and implementation of the State Pharmacopoeia of the Republic of Uzbekistan".

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