Pharmacovigilance in Kyrgyzstan in 2026: MAH Requirements

Updated 15 July 2026. Pharmacovigilance in the Kyrgyz Republic is governed by national legislation and applicable Eurasian Economic Union (EAEU) law. Marketing authorisation holders (MAHs) must ensure that a pharmacovigilance system operates in the country and that the benefit-risk balance of their medicines is continuously monitored.

Authority and legal framework

The competent authority is the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic. It publishes pharmacovigilance legislation, MAH guidance and medicine-safety communications.

• Law of the Kyrgyz Republic on the Circulation of Medicines No. 13 of 12 January 2024.
• Cabinet of Ministers Resolution No. 546 of 6 September 2024, approving the Pharmacovigilance Procedure.
• Order No. 1073 of 3 October 2024, implementing Resolution No. 546 and approving the notification form.
• The EAEU Good Pharmacovigilance Practice Rules, approved by EEC Council Decision No. 87 of 3 November 2016, as amended, including Decision No. 81 of 19 May 2022.

The regulatory status of each nationally or EAEU-authorised product must be checked. The Department states that nationally registered dossiers were to be brought into compliance with Union requirements by the end of 2025; product-registration status is therefore an important compliance point in 2026.

Core MAH obligations

Pharmacovigilance system and PSMF

An operational pharmacovigilance system is a condition for keeping a medicine on the market. The MAH should maintain a current Pharmacovigilance System Master File (PSMF) and document processes, databases, agreements, training, quality indicators, audits and CAPA.

Responsible persons and local availability

A suitably qualified pharmacovigilance person and the required local contact should be designated. Their authority, contact details, back-up arrangements and access to safety information must remain current.

Adverse-reaction reporting

Processes should cover intake, validation, medical assessment, follow-up, duplicate detection and submission of individual case safety reports within applicable timelines. Sources include healthcare professionals, patients, literature, studies, support programmes and business partners.

Literature and regulatory monitoring

Monitoring frequency must support timely detection and reporting of new safety information. A universal weekly frequency should not be claimed for every product without a specific regulatory and procedural basis. Sources, languages, search strategies and quality controls should be documented.

PSURs, RMPs and signals

MAHs should manage periodic safety-report schedules, maintain the Risk Management Plan, assess signals and evaluate risk-minimisation measures. New evidence may require changes to product information, the dossier or additional measures.

Inspection readiness

1. Verify each product’s registration status in 2026.
2. Update the PSMF, SOPs and responsible-person contacts.
3. Reconcile cases with distributors and vendors.
4. Review ICSR and periodic-report deadlines.
5. Update RMPs, signals and risk-minimisation measures.
6. Review training, deviations, CAPA and audit trails.
7. Ensure safety agreements allocate responsibilities and data-exchange timelines.

Conclusion

Pharmacovigilance in Kyrgyzstan in 2026 requires coordinated compliance with national requirements and applicable EAEU rules. MAH priorities are an operational system, a current PSMF, accessible responsible persons, timely ICSRs and reports, signal management and inspection readiness.

PharmExpert supports MAHs with local pharmacovigilance in Kyrgyzstan, including PSMF maintenance, local contacts, case processing, literature and regulatory monitoring, PSURs, RMPs, signal management, audits and inspection preparation.

Official sources

1. Department of Medicines: pharmacovigilance legislation.
2. Pharmacovigilance information for MAHs.
3. Medicines registration information.
4. EEC: common pharmacovigilance-system inspection rules.

This article provides general information only. Before taking regulatory action, verify the current requirements and product status.