The State Pharmacopoeia: History and Legal Foundations

The State Pharmacopoeia of the Republic of Uzbekistan is the official regulatory foundation of the national medicines-quality system. Its legal basis was established at the level of law in 2016 and has since been steadily expanded through a Presidential decree and orders of the Ministry of Health, and developed in line with modern international standards.

Legal foundation

The system rests on the Law “On Medicines and Pharmaceutical Activity” No. ZRU-399, adopted on 4 January 2016. Its Article 8 defines the State Pharmacopoeia as the official publication that consolidates, in a single document, the requirements for medicines and medical devices, monographs, and quality-control methods.

Development on the basis of international standards

Presidential Decree No. PF-5707 of 10 April 2019, adopted as part of the measures for the accelerated development of the country's pharmaceutical sector (2019–2021), set the task of developing and approving the State Pharmacopoeia on the basis of modern international standards. Shortly afterwards, Order No. 115 of the Ministry of Health of 3 May 2019 established the working groups and expert bodies for compiling the Pharmacopoeia.

That same year, an agreement was reached with the European Pharmacopoeia (EDQM) on the right to harmonize and reproduce texts. In 2023 cooperation broadened further: on 12 May a contract was signed with USP on the rights to adopt the United States Pharmacopeia–National Formulary, followed by a memorandum of understanding on 8 September.

Official approval of the editions

These efforts were formalized through successive orders: Order No. 258 of 6 August 2024 approved the appendix to Volume 1 of the first edition, and Order No. 404 of 29 December 2025 approved Volume 1 of the second edition.

Key legal instruments

• 4 January 2016 — Law “On Medicines and Pharmaceutical Activity” No. ZRU-399: Article 8 establishes the State Pharmacopoeia as the official publication setting out the requirements for medicines and medical devices, monographs, and quality-control methods.
• 10 April 2019 — Presidential Decree No. PF-5707: within the framework for the accelerated development of the pharmaceutical sector (2019–2021), it set the task of developing and approving the State Pharmacopoeia on the basis of modern international standards.
• 3 May 2019 — Order No. 115 of the Ministry of Health: the working groups and expert bodies for compiling the State Pharmacopoeia were established.
• 2019 — an agreement was reached with the European Pharmacopoeia (EDQM) on the right to harmonize and reproduce texts.
• 12 May 2023 — contract with USP on the rights to adopt the United States Pharmacopeia–National Formulary; 8 September 2023 — memorandum of understanding.
• 6 August 2024 — Order No. 258 of the Ministry of Health: the appendix to Volume 1 of the first edition was approved.
• 29 December 2025 — Order No. 404 of the Ministry of Health: Volume 1 of the second edition was approved.

Since the system was established, more than 20 orders have been adopted concerning the formation of expert bodies, the approval of editions, and individual monographs — a testament to the steady and continuous development of the State Pharmacopoeia.