Pharmacovigilance in Uzbekistan in 2026: MAH Requirements

Pharmacovigilance in Uzbekistan in 2026: New MAH Requirements

Updated 15 July 2026.

Uzbekistan substantially updated its pharmacovigilance framework in 2026. Ministry of Health Order No. 18 of 30 December 2025 approved the Regulation on the Procedure for Pharmacovigilance of Medicinal Products and Safety Monitoring of Medical Devices. It was registered by the Ministry of Justice as No. 3752 on 12 January 2026 and establishes mechanisms for continuous safety oversight.

National Standard O‘z MSt 339:2024 “Good Pharmacovigilance Practice (GVP)” was developed by the Center for Pharmaceutical Products Safety with the specialised standards institute under Presidential Decree No. PF-20 of 23 January 2024 and took effect on 1 November 2024. It establishes the framework for safety control, timely detection of changes in the benefit–risk balance and implementation of appropriate risk-management measures.

Competent authority

The specialised regulatory institution is the State Institution “Center for Pharmaceutical Products Safety” under the Ministry of Health of Uzbekistan. The Center performs state registration and post-marketing control of medicines, publishes safety information and receives adverse-reaction reports.

Uzbekistan is not an EAEU Member State. EAEU pharmacovigilance rules therefore do not apply automatically; the national Regulation, Uzbekistan GVP standard, marketing authorisation conditions and formal decisions of the Center take priority.

Scope of the 2026 procedure

• detection, documentation, assessment and prevention of adverse reactions;
• evaluation of cases of lack of efficacy;
• monitoring of adverse events and incidents involving medical devices;
• continuous benefit–risk evaluation;
• safety-signal detection, assessment and prompt regulatory action;
• mandatory notification of the competent authority within defined timelines when a situation threatens human life or health.

MAH responsibilities

The new procedure defines duties for manufacturers, marketing authorisation holders, healthcare institutions, pharmacies and distributors. An MAH should maintain an operational pharmacovigilance system aligned with the national GVP standard.

• GVP system: documented roles, procedures, training, quality control, record retention and inspection readiness.
• Case management: accessible intake channels, validation, medical review, follow-up and submission within national timelines.
• Risk management plan: development and maintenance of an RMP covering identified and potential risks, missing information and risk-minimisation measures.
• Periodic reporting: preparation and submission of periodically updated safety reports under the applicable regulatory procedure.
• Signals and benefit–risk: continuous review of cumulative data, literature and regulatory information, with documented conclusions and actions.
• Partner oversight: written agreements defining safety-data exchange timelines, responsibilities and compliance controls.

Who may report an adverse reaction?

The Center’s official online service accepts reports from marketing authorisation holders, healthcare and pharmaceutical professionals, and members of the public. Reporting is available through government web resources, a Telegram bot and mobile applications. Companies should retain proof of submission and protect personal data.

MAH readiness checklist

1. Perform a gap assessment against Regulation No. 3752 and the national GVP standard.
2. Verify responsible personnel, back-up coverage and local contacts.
3. Update procedures for ICSR management, signals, RMPs, periodic reporting and urgent safety action.
4. Review safety-data exchange agreements with distributors and service providers.
5. Train employees on the new requirements and document completion.
6. Review deadline controls, quality metrics, CAPA and inspection readiness.

Official sources

• Introduction of National Standard O‘z MSt 339:2024 from 1 November 2024.
• New pharmacovigilance procedure: Order No. 18 and registration No. 3752.
• Center for Pharmaceutical Products Safety: pharmacovigilance.
• Official online adverse-reaction reporting.
• Center document database.

How PharmExpert can help

PharmExpert supports compliance with Uzbekistan pharmacovigilance requirements through GVP gap assessments, procedures, RMPs and periodic reports, case management, partner oversight, training and inspection readiness.

This article is for general information and is not legal advice. Applicable formats and timelines should be confirmed against current legislation and product-specific authorisation conditions.