Pharmacopeia Committee

The Pharmacopoeial Committee, in accordance with Resolution No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan dated November 24, 2025, «On Approval of the Regulation on the Procedure for State Registration of Medicines and the Regulation on the Procedure for State Registration of Medical Devices»:

• Conducts evaluation of the administrative, chemical, pharmaceutical and biological sections of medicinal product registration dossiers, including laboratory testing protocols.
• Requires applicants to include alternative and/or additional specifications, acceptance criteria, and testing methods in draft regulatory documents for medicinal products in order to harmonize them with national and international requirements.
• Conducts evaluation and re-evaluation of pharmacological documentation and/or medicinal product dossiers with the involvement of independent experts.
• Submits samples and documentation of medicinal products to the laboratories of the State Center.
• Approves regulatory documentation for medicinal products and medical devices.
• Based on the submitted documentation and expert conclusions, submits to the Expert Council, established by the Ministry of Health of the Republic of Uzbekistan in accordance with the established procedure (hereinafter referred to as the “Expert Council”), recommendations regarding the registration of medicinal products or refusal to register such products.

The Pharmacopoeial Committee has developed requirements for medicinal products in accordance with scientific and technological advances aimed at improving the quality and quality assurance of medicinal products for the benefit of consumers.
Particular importance is attached to strengthening requirements and harmonizing technical regulations and regulatory documents developed to ensure the efficacy and safety of medicinal products, medical devices, and medical equipment with The International Pharmacopoeia, The European Pharmacopoeia, The United States Pharmacopeia, and other internationally recognized pharmacopoeias. Approved regulatory documents have been harmonized with international requirements.
For the implementation of the Law of the Republic of Uzbekistan «On Technical Regulation», the Pharmacopoeial Committee established a fund of regulatory documentation in both electronic and hard-copy formats containing more than 14,000 regulatory documents related to medicinal products.
In implementation of this Law, and for the purpose of establishing uniform safety requirements for medicinal products, the Pharmacopoeial Committee developed the General Technical Regulation on the Safety of Medicinal Products, approved by Resolution No. 365 of the Cabinet of Ministers of the Republic of Uzbekistan dated October 27, 2016.