Regulation of Clinical Trials in the Republic of Uzbekistan

What is a clinical trial?

Clinical trials (“CT”) of pharmacological products (“PP”) or medicinal products (“MP”) are defined as studies involving human subjects conducted to investigate the pharmacological properties, side effects, and interactions with other MP in order to determine the safety and efficiency of MP/PP.

What types of CTs can be conducted in the Republic of Uzbekistan (“Uzbekistan“)? 

CT of MP/PP may be conducted in a single medical and preventive institution (“Clinical Base”) or according to a single protocol in the form of a multicenter (interventional) CT in more than one Clinical Base.

In Uzbekistan, the main legal acts regulating CTs are:

• Law of Uzbekistan “On Medicines and Pharmaceutical Activities” dated January 4, 2016, No. 399
• It regulates the basic requirements for CT.
• Resolution of the Cabinet of Ministers of Uzbekistan “On Measures to Develop CTs of MPs and Organize their Conduct in Accordance with International Standards” dated April 14, 2022, No. 181
• The resolution defines the legal basis for the organization of the State Enterprise “Center for CT Development” (“Center”)and describes its main responsibilities.
• Order of the Minister of Health of Uzbekistan on the Approval of the Regulation “On the Procedure for Conducting CT of MP/PP” dated June 5, 2023, No. 3439
• It defines the legal basis for regulating and conducting CT of MP/PP within the framework of state registration of MP/PP. It should be noted that, in the absence of a regulatory act governing the conduct of independent CT, this ministerial order also applies to the independent CTs, carried out outside the framework of state registration of MP/PP.

Key Regulatory Bodies

Ministry of Health of Uzbekistan (“MH”)

• approves the CT of MP/PP on humans,
• approves the procedure for conducting CT of MP/PP and the list of Clinical Bases where CT are conducted.

Pharmaceutical Industry Development Agency

• organizes the examination of the results of preclinical trials and CT of MP/PP and medical devices (“MD“),

ensures the state registration, quality control, standardization, and certification of MP/PP, MD, and medical equipment.

• organization of CT of MP/PP in accordance with the requirements of Good Clinical Practice (GCP),
• determination of the pharmacological bioequivalence of generic MP to original MP,
• conducting pharmacokinetic studies of MP/PP in CT subjects,
• improving the qualifications of medical workers in the field of conducting CT,
• International cooperation in the field of Good Clinical Practice (GCP).

Pharmacology Committee (“PC”) at the Center

• The structural subdivision of the Center responsible for issues related to CT of MP/PP.

Clinical Base 

• Medical and preventive institutions that can perform CT of MP/PP  included in the list approved by the MH.

Ethics Committee (the “Committee”)

• A permanent collegial body operating on a voluntary basis, approved by the MH and consisting of representatives of medical and research organizations, higher education institutions, the media, non-governmental non-profit organizations, and other civil society institutions. The Committee conducts ethical reviews of the ethical validity of CT.

Board of Experts (the “Board”)

decides whether to approve or reject the use of MP/PP in medical practice.

Is notification/permission required to conduct CT in Uzbekistan?

• As part of the state registration of MP/PP, based on the recommendation of the PC, the Board shall, within one working day of receiving the relevant recommendation, decide on the conduct of a CT.
• Within one working day of the decision being made by the Board of PC, the applicant will receive a notification via the electronic system indicating the possibility of conducting a CT.
• With regard to conducting independent CT of MP/PP on humans in Uzbekistan, it is mandatory to obtain permission from the MH. However, there are no specific regulations or procedures for obtaining such permission in the current legislation.
• MH, which reviews the application in accordance with international ICH GCP standards for issuing a CT permit.
• After approval by the MH, the applicant submits the documents to the Center, where the request is reviewed in accordance with internal rules.
• The procedure applies to applications from individuals and legal entities and does not constitute a procedure for conducting independent CT due to the lack of legal grounds.

What are the requirements for participating in the CT?

• Obtaining a written consent:A subject may be included in a CT only if he or she or his or her legal representative has received information regarding the nature and possible consequences of the CT, the properties of the MP/PP, its expected efficacy, and the degree of risk, and has given his or her Consent to participate in the CT.

Restrictions on participation in CTs for certain categories of persons. In cases where the CT is conducted with the participation of a minor or incapacitated person, the consent of their legal representative must be obtained prior to the commencement of the CT.

Requirements for Clinical Bases Conducting CT.

• The Clinical Base included in the list approved by the MH must have a legal address, seal, and bank account with the Republic of Uzbekistan.
• Material resources (laboratory and diagnostic equipment, instruments, tools, etc.) that enable the effectiveness and safety of the tested product to be assessed in accordance with international standards.
• High scientific qualifications of the Clinical Base’s staff.
• Existence of an ethics committee.

Result of Conducting CT

• Upon completion of a CT, an applicant is issued individual registration forms and CT’s subject consent forms signed by the CT director and research physicians. Based on the results of the CT, a CT report is compiled. The CT report is approved by the director of the Clinical Base and is submitted to the applicant.
• The CT report for state registration of MP/PP submitted by the applicant is sent for final review by the PC within 15 days.
• The review is conducted to verify that the CTs conducted comply with the approved protocol.
• If there are no discrepancies between the report and the CT protocol, the results of the final review are sent to the Board.

With regard to an independent CT, in the absence of a separate procedure after completing the CT, the Center issues a report to the applicant based on the Center’s internal rules, similar to the procedure described above. Next, the PC conducts a final review of the CT in accordance with the approved CT protocol.