Procedure for the Application of Test Methods from Leading Pharmacopoeias in the Standardization of Medicinal Products Approved

In accordance with Article 8 of the Law of the Republic of Uzbekistan dated January 4, 2016 No. LRU–399 “On Medicines and Pharmaceutical Activities,” the State Pharmacopoeia shall be published by the Ministry of Health of the Republic of Uzbekistan at least once every five years.

At present, the global pharmaceutical sector is developing at a rapid pace, with new-generation medicines, modern analytical methods, and innovative technologies continuously being introduced into medicine and pharmacy. Consequently, the test methods of pharmacopoeial monographs, which serve as quality standards for thousands of medicinal products in circulation, require regular improvement. To comprehensively cover all medicinal products in circulation and modern analytical methods, each leading pharmacopoeia, including the State Pharmacopoeia of the Republic of Uzbekistan, requires a certain period of time.

In order to create favorable conditions for entities operating in the pharmaceutical industry and in the field of medicinal product quality control, it is considered appropriate to apply test methods established by leading international pharmacopoeias in cases where such methods have not yet been included in the State Pharmacopoeia.

Based on the above, with the aim of further improving the system for ensuring the quality of medicinal products and their assessment in line with international requirements, Order No. 15 of the Minister of Health of the Republic of Uzbekistan dated December 12, 2025 approved the procedure for applying test methods established by leading world pharmacopoeias in cases not provided for by the State Pharmacopoeia of the Republic of Uzbekistan.

This document was developed in accordance with the Presidential Decree of the Republic of Uzbekistan dated August 19, 2025 No. PF–137 “On Additional Measures to Regulate the Circulation of Medicinal Products and Medical Devices,” as well as the Resolution of the Cabinet of Ministers dated November 24, 2025 No. 738 “On Approval of Regulations on the Procedure for State Registration of Medicinal Products and Medical Devices,” and represents a consistent continuation of reforms in the field of regulating the circulation of medicinal products and medical goods.

Under the new procedure, interested parties must, prior to the development of a medicinal product, analyze the availability of relevant test methods in the State Pharmacopoeia, their accuracy, and applicability. If the required test methods are absent or cannot be applied, the use of test methods established by the European, United States, and Japanese Pharmacopoeias, as well as the International Pharmacopoeia of the World Health Organization and the pharmacopoeias of member states of the Pharmacopoeial Discussion Group (PDG), is permitted, with priority given to the European Pharmacopoeia.

Based on the selected test methods, laboratory testing is conducted and subsequently verified, meaning that the suitability of the test method for achieving the intended objectives is practically demonstrated under laboratory conditions. The results obtained are included in the draft pharmacopoeial monograph of the enterprise, and the purpose, advantages, and assessed quality attributes of the test methods are substantiated in an explanatory note.

These documents undergo specialized expert review in accordance with the established procedure by the “Center for Pharmaceutical Product Safety” under the Ministry of Health of the Republic of Uzbekistan. This approach expands opportunities for assessing the quality of medicinal products based on international criteria, establishes a clear and transparent regulatory mechanism for pharmaceutical manufacturers, and contributes to ensuring the population’s access to safe, high-quality, and effective medicinal products.

This order has been registered with the Ministry of Justice of the Republic of Uzbekistan and shall enter into force on February 26, 2026.