Two draft regulations prepared in execution of Presidential Decrees

The State Pharmacopoeia Development Department of the State Institution "Center for Safety of Pharmaceutical Products" has prepared two draft regulations in execution of two decrees of the President of the Republic of Uzbekistan and submitted them to the relevant ministries and agencies for coordination.

The first document was drawn up to implement the tasks set out in Presidential Decree No. PF-137 of 19 August 2025 "On additional measures to regulate the circulation of medicines and medical devices." The draft regulation "On the procedure for applying the test methods of the world's leading pharmacopoeias in cases not covered by the State Pharmacopoeia of the Republic of Uzbekistan in the standardization of medicines" sets out how analyses and tests are to be carried out using the methods of leading international pharmacopoeias wherever the national pharmacopoeia is silent.

The second draft — the regulation "On the development of general pharmacopoeial monographs and pharmacopoeial monographs and their inclusion in the State Pharmacopoeia" — was prepared in execution of Presidential Decree No. PF-161 of 8 September 2025 "On measures to raise the effectiveness of the legal framework for reforms and to strengthen the responsibility and initiative of ministries and agencies in regulating social relations." It governs the procedure for developing general pharmacopoeial monographs and pharmacopoeial monographs and incorporating them into the State Pharmacopoeia.

Both drafts are currently at the interagency coordination stage. Once adopted, they will strengthen the legal foundation for developing the State Pharmacopoeia and for national medicines-standardization work.