First Volume of the State Pharmacopoeia's Second Edition Completed and Submitted for Approval

In accordance with the strategic work plan approved by the Department for the Development of the State Pharmacopoeia (Department), in the direction of developing the second edition of the State Pharmacopoeia of the Republic of Uzbekistan:

1. The State Pharmacopoeia of the Republic of Uzbekistan (State Pharmacopoeia) to ensure the fulfillment of the tasks established by the Law of the Republic of Uzbekistan" On Medicines and Pharmaceutical Activities" and the Order of the Minister of Health No. 258 "On approval of the first volume of the first edition of the State Pharmacopoeia of the Republic of Uzbekistan "Volume 1 of the second edition contains about 450 general pharmacopoeia articles signed by the State Institution "Center for Pharmaceutical Product Safety" and the European Pharmacopoeia Agreement "On Granting the Right to Copy and Harmonize the Texts of European Pharmacopoeia in the Creation of the State Pharmacopoeia of the Republic of Uzbekistan", as well as with the US Pharmacopoeia Convention (USP) It was developed in accordance with the Agreement on Granting the Rights to Adopt the United States Pharmacopoeia – National Formula" and the "Memorandum of Understanding".

At the same time, the European Pharmacopoeia was carried out on the basis of a specific analysis of the revisions, additions, additions and omitted and currently valid pharmacopoeia articles between the 9th and 12th editions of the European Pharmacopoeia. The analyses were carried out on the basis of data from the Pharmeuropa platform of the EDQM , meeting decisions of the European Pharmacopoeia Commission, strategic work plans.

According to the results of the study, over the past 5 years after the first volume of the State Pharmacopoeia was developed, a total of 131 new pharmacopoeia monographs have been introduced into the European Pharmacopoeia (between 8th and 12th editions), 875 pharmacopoeia monographs have been amended and supplemented accordingly, 37 pharmacopoeia monographs have been excluded from the European Pharmacopoeia and their validity has been suspended, and 6 monographs are directly related to the State Pharmacopoeia.

2. The list of pharmacopoeia articles to be included in the state pharmacopoeia was formed, scientific translation and editing, editing, text correction and pagination of selected pharmacopoeia articles into Uzbek and Russian languages were carried out.

3. During 2025, the Editorial Board of the State Pharmacopoeia, the Editorial Council, the Secretariat of the State Pharmacopoeia, the Specialized Expert Commissions of 11 directions and their Working Groups held more than 50 meetings, where a total of about 200 various issues were discussed and about 450 draft pharmacopoeia articles were discussed, including about 10Drafts of pharmacopoeia articles were sent for processing and, after approval by experts, were recommended for inclusion in the State Pharmacopoeia. A total of 40 meetings were recorded.

4. Volume 1 of the 2nd edition of the State Pharmacopoeia included 17 new articles of the European Pharmacopoeia and 30 new articles of the U.S. Pharmacopoeia . At the same time, 17 pharmacopoeia articles cross-harmonized by European and US pharmacopoeias within the framework of the Pharmacopoeia Discussion Group (PDG) were included in Volume 1 of the 2nd edition of the State Pharmacopoeia, which included 14 articles submitted by the USP as an alternative article.

In addition, systematic work was carried out on the harmonization, modification and replenishment of more than 200 fillings and amendments, as well as about 4 thousand reagents included in Volume 1 and their inclusion in the 2nd edition of the State Pharmacopoeia

5. The Department has been discussing a total of 7 general pharmacopoeia articles that are being excluded from the European pharmacopoeia from January 1, 2026 in order to reduce animal testing, abandon outdated testing methods and replace them with alternative methods, and in this regard, it was proposed to phase out these testing methods in the State Pharmacopoeia for 3 years, taking into account local conditions.

6. The first volume of the second edition of the State Pharmacopoeia of the Republic of Uzbekistan was developed by the Department in coordination with the leading international pharmacopoeia in ensuring the quality of pharmaceutical products: the International Pharmacopoeia (Ph. Int.), the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP), and submitted a draft order to the Ministry of Health for its approval.