First Volume of the Second Edition of the State Pharmacopoeia Approved

Decree of the Minister of Health of the Republic of Uzbekistan for 2025 In order to ensure the execution of Order No. 404 of December 29 "On approval of the first volume of the second edition of the State Pharmacopoeia of the Republic of Uzbekistan":

I.1. Work on the layout of the 1st volume of the 2nd edition of the State Pharmacopoeia was carried out and a draft in electronic form was prepared.

At the same time, the European Pharmacopoeia, which is planned to be included in Volume 1 of the 2nd edition of the State Pharmacopoeia 334 monographs, State Pharmacopoeia
Included in the Appendix of the 1st Edition 51 monographs and the 9th to 12th editions of the United States Pharmacopoeia (USP) Translations and edits of 22 monographs, including changes, additions and omitted texts, have been completed.

I.2. A draft of the terms of reference for the publication of the 1st volume of the 2nd edition of the State Pharmacopoeia in printed (book) and electronic form has been developed.

I.3. A draft order has been developed for the distribution of books and electronic copies of the 2nd edition of the State Pharmacopoeia free of charge to the members of the Editorial Board and the Editorial Council of the State Pharmacopoeia to the members of the Editorial Board and the Editorial Council of the State Pharmacopoeia of the 2nd edition, as well as to the structural divisions of the Center.

I.4. On February 12, 2026, a special seminar was organized in the form of a webinar on the topic "2nd edition of the State Pharmacopoeia: a new stage in the combination of international and modern requirements" for organizations and institutions carrying out research work on the creation of local medicines, manufacturers of medicines and medical equipment and their quality control.

Photo from the webinar "2nd edition of the State Pharmacopoeia: a new stage in the harmonization of international and modern requirements"

I.5. In accordance with the decision of the meeting of the Editorial Council of the State Pharmacopoeia dated December 11, 2025 No. 12 on making appropriate additions, amendments and additions to the texts of the State Pharmacopoeia and making proposals for the exclusion of articles that are becoming irrelevant, the Order No. 36 of the Director of the State Institution "Center for the Safety of Pharmaceutical Products" dated January 27, 2026 "On termination or limitation of the validity of certain pharmacopoeia articles" was signed and according to which:

Taking into account the fact that the following pharmacopoeia articles have been summarized and improved on the basis of modern requirements, with similar, alternative pharmacopoeia articles in the relevant areas, their validity has been terminated:

2.2.60. Temperature of liquidation – instrumental method of detection;

2.6.19. Neurovirulence test of (oral) vaccine for the prevention of poliomyelitis.

In addition, in order to facilitate the activities of pharmaceutical enterprises, it is determined that the following pharmacopoeia articles excluded from the European Pharmacopoeia from January 1, 2026, with a transition period of up to 5 years, will be included in the second edition of the State Pharmacopoeia:

2.6.9 Anomalous toxicity;

5.14 Medicines used for gene therapy in medical practice;

2.6.8 Pyrogens;

2.6.10 Histamine;

2.6.11 Depressant substances.

I.6. The development of the second volume of the second edition of the State Pharmacopoeia continues, with the continuation of work on the development of the State Pharmacopoeia for publication, preparation for publication (republication), making special changes and addenda to it .

At the same time, the "State Register of medicines and medical devices approved for use in medical practice in the Republic of Uzbekistan" will be analyzed based on the needs of the republic, and the selection of pharmacopoeia articles planned for inclusion in the second volume of the second edition is underway on the basis of cross-comparison with pharmacopoeias of Europe and the USA.

II. To ensure the implementation of the Orders of the Minister of Health dated December 12, 2025 No. 14 "On approval of the Regulation on the procedure for the development of general pharmacopoeia articles and their inclusion in the State Pharmacopoeia" and No. 15 "On approval of the Regulation on the procedure for the use of testing methods of the world’s leading pharmacopoeias in cases not listed in the State Pharmacopoeia of the Republic of Uzbekistan in the standardization of medicines":

II.1. In order to ensure the development of general pharmacopoeia articles, pharmacopoeia articles and their inclusion in the State Pharmacopoeia of the Republic of Uzbekistan in accordance with the requirements of the approved Regulation, as well as to convey the content and essence of the Order, a webinar was organized by the Secretariat of the State Pharmacopoeia on February 12 and March 11, 2026 at the State Institution "Center for Safety of Pharmaceutical Products". In total, more than 300 specialists took part in it online and offline.

II.2. Based on the requirements of Regulation, relevant changes and additions were made to the Standard Operating Procedures (SOP), approved for the Quality Management System of the Center and approved by the Director of the Center.

III. Implementation of the agreement concluded between the Ministry of Health of the Republic of Uzbekistan and the European Directorate for Medicines and Health Quality (EDQM) dated March 20, 2019, to continue work on harmonization of the State Pharmacopoeia of the Republic of Uzbekistan 2nd edition with the 12 editions of the European Pharmacopoeia

III.1. The 12th edition of the European Pharmacopoeia with the 2nd edition of the DF of the Republic of Uzbekistan was carried out on a comparative analysis of the 2nd volume.

Photo from the webinar dedicated to the introduction of the State pharmacopoeia of the Republic of Uzbekistan

III.2. Work is underway on the translation of the selected pharmacopoeia articles into Uzbek and Russian languages for inclusion of additions and amendments to the European pharmacopoeia in the DF of the Republic of Uzbekistan.

IV. Implementing the Agreement between the Ministry of Health of the Republic of Uzbekistan and the US Pharmacopoeia Convention (USP) on the "Granting of the rights to adopt the United States Pharmacopoeia – National Formula" signed on May 12, 2023 and the Memorandum of Understanding signed on September 08, 2023, in order to harmonize the pharmacopoeia articles of the 2nd edition of the DF of the Republic of Uzbekistan with the USP 2025 edition:

IV.1. The USP 2025 edition has been analyzed with the 2nd edition of the DF of the Republic of Uzbekistan.

IV.2. Translation of pharmacopoeia articles into Uzbek and Russian languages is underway for inclusion in the DF of the Republic of Uzbekistan available in the USP 2025.