Rapid Evolvement of Uzbekistan Pharmacovigilance System

Just several years ago Uzbekistan Phartmacovigilance system was considered as less matured comparing with other countries in a region. However, in recent years, this country evolves their vigilance requirements for medicinal products and medical devices very rapidly, requiring keeping attention and implement required measures at MAH to stay compliant.

The latest major changes start appearing since late 2024. The initial requirements for the reporting safety information, the submission of PSUR, RMP, and the general requirements for the PSMF were set out in the local GVP, which entered into force on November 01, 2024. The new document, in the form of Ministry of Health Order No. 3752, published in the beginning of 2026 became effective on April 15, 2026. This was a major change requiring MAHs to implement appropriate measures and processes in a quick manner. For MAHs, the following Chapters of the Order are of particular interest:

Chapter 2. “Reporting of adverse reactions or ineffectiveness of medicines detected during their use”.

Specific reporting timelines were indicated for a different type of local cases, which in many situations are shorter compared to international standards.

Reporting criteria for local cases are as follows:

• fatal or life-threatening ADR – within 1 day from the date of detection;
• ADR requiring hospitalization or prolongation of hospitalization, leading to disability, congenital anomalies or developmental disorders — within 15 days from the date of detection;
• other ADR harmful to the human body – within 60 days from the date of detection;
• lack of efficacy — within 30 days from the date of detection.

The reporting timelines for foreign cases are align to international standards:

• serious unexpected (in line with GVP) ICSR – within 15 days from the date of detection;

MAHs shall take into attention these different timelines while setting their global PV system and global case processes to keep compliance.

Chapter 4. “Organization of pharmacological supervision among manufacturers of medicines and marketing authorization holders of medicines.”

There were a lot of other implications to pharmacovigilance system in Uzbekistan to ensure its robustness. Of particular attention are the following:

• Collection, systematization and coding of information on cases of ADR, inefficiency and errors in the use of appropriate medicines in accordance with the MedDRA system, as well as provision of such information to the authorized body on a quarterly basis;
• Informing NCA within 10 days from the date of detection of any prohibitions or restrictions imposed on this medicinal product in other countries, as well as any information that may affect the assessment of the benefit—risk ratio;
• RMP development for original, generic, biological, biosimilar, biotechnological and immunological medicines and its submission to NCA within 30 days from the date of identification of new risks;
• Appointment of LPPV with a higher medical or pharmaceutical education and relevant qualifications (certificate) in pharmacological supervision to comply with the requirements of pharmacological supervision in the Republic of Uzbekistan. It is mandatory to make NCA informed of LPPV change within 30 days;
• MAHs had to submit new version of PSMF to NCA until 1^st of June 2026;
• Conducting a PV audit at least every two years in accordance with the national standard “Good Pharmacovigilance Practice” and entering the audit results into PSMF.
• Before the end of the first quarter of each year, MAH is obliged to prepare an annual report on the assessment of the benefit-risk ratio for all registered medicines and submit it to the authorized body every year until the end of 2030 inclusive;
• In case of gathering ADR during PV activities or if there is such official information on NCA website, MAHs are required to make the necessary changes to the instructions for use of the medicinal product no later than 30 days from the date of detection of ADR.

In addition, Chapter6 of Decree explains what MAHs in Uzbekistan should expect in relation to inspections held by NCA.

The same Decree describes requirements for Medical Devices. Those can be found under the Chapter 7 and 9 explaining the reporting requirements of incidents or adverse reactions detected during the use of medical devices as well as the requirement to prepare and submit annual benefit-risk reports of any medical device for three years.

The latest update was published in the beginning of June 2026, which requires MAHs to collect set a document and make a registration to the new electronic reporting system managed by UZ Authority in a very short timeline up until 20^th of June 2026.

It is expected that additional clarifications and guidance about the use of the system will be available at a later stage, thus this is not the last update MAHs should keep the eye on.