The procedure for developing general pharmacopoeial monographs, pharmacopoeial monographs and their inclusion in the State Pharmacopoeia has been established

In carrying out quality control of medicinal products and medical devices in the Republic of Uzbekistan, priority is given to the general pharmacopoeial monographs, pharmacopoeial monographs and testing methods established in the State Pharmacopoeia of the Republic of Uzbekistan.

It is stipulated that, in resolving possible deviations or disputable situations arising in the quality control of medicinal products and medical devices, including issues related to testing and determination of quality indicators, the requirements of the State Pharmacopoeia shall be applied.

Based on the above, the development of pharmacopoeial monographs, their expert evaluation, and their inclusion in the State Pharmacopoeia on the basis of laboratory test results require particular relevance and a high level of responsibility.

The level of development of the pharmaceutical sector in a country can be assessed by the degree to which its national or regional pharmacopoeial monographs are developed and improved in accordance with modern requirements.

In order to improve the system of technical regulation of the quality of medicinal products and medical devices in the Republic of Uzbekistan, by Order No. 14 of the Minister of Health of the Republic of Uzbekistan dated 12 December 2025, the Regulation on the procedure for developing general pharmacopoeial monographs and pharmacopoeial monographs and their inclusion in the State Pharmacopoeia was approved.

This document was developed in accordance with the Law of the Republic of Uzbekistan dated 4 January 2016 No. ZRU-399 “On Medicinal Products and Pharmaceutical Activities” and the Decree of the President of the Republic of Uzbekistan dated 8 September 2025 No. PF–161 “On measures to enhance the effectiveness of legal support for reforms and to strengthen the responsibility and initiative of ministries and agencies in regulating social relations”. The Regulation is aimed at ensuring the consistent continuation of reforms in the pharmaceutical sector and harmonizing the processes of standardization of medicinal products with international experience and the achievements of modern science.

In developing the Regulation, international experience was analysed, and procedures applied in the pharmacopoeias of developed countries were taken into account, in particular the International Pharmacopoeia of the World Health Organization (Ph. Int.), the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP).

The new Regulation establishes a unified and clear procedure for the development of general pharmacopoeial monographs and pharmacopoeial monographs, their scientific and practical substantiation, and their inclusion in the State Pharmacopoeia.

The Regulation clearly defines the requirements for the structure and content of general pharmacopoeial monographs and pharmacopoeial monographs. It is stipulated that their text shall be concise, clear and presented in the state language, be scientifically substantiated, and, where equivalent terms and concepts exist in the state language, be free from foreign terminology, colloquial forms and figurative expressions. The preparation of pharmacopoeial monographs shall also take into account international standards, leading global pharmacopoeias and the achievements of modern science.

The process of developing pharmacopoeial monographs is organized by the State Institution “Center for the Safety of Pharmaceutical Products” under the Ministry of Health of the Republic of Uzbekistan, with the participation of working groups, a specialized expert commission, an editorial board and an editorial committee. Drafts undergo scientific evaluation and are submitted to the Ministry for approval based on established criteria.

Approved general pharmacopoeial monographs and pharmacopoeial monographs are included in the State Pharmacopoeia, with the implementation period set at not less than six months. The Regulation also establishes the procedure for amending, supplementing or excluding pharmacopoeial monographs from the State Pharmacopoeia, taking into account scientific and technological progress and practical needs.

This Order has been registered with the Ministry of Justice of the Republic of Uzbekistan and enters into force from the date of its official publication.