Pharmacovigilance in Kazakhstan in 2026: MAH Requirements

Updated 15 July 2026. Pharmacovigilance in Kazakhstan is governed by national legislation and applicable Eurasian Economic Union (EAEU) law. Marketing authorisation holders (MAHs) therefore need to consider the regulatory status of each product, maintain an operational pharmacovigilance system and comply with national safety-monitoring requirements.

Pharmacovigilance authorities in Kazakhstan

• The Ministry of Health of the Republic of Kazakhstan sets state healthcare policy.
• The Committee for Medical and Pharmaceutical Control performs regulatory and oversight functions.
• The National Center for Expertise of Medicines and Medical Devices (NCEM) supports safety-data assessment, benefit-risk monitoring and processing of adverse-reaction notification cards.

Current legal framework

• The Code of the Republic of Kazakhstan on Public Health and the Healthcare System.
• Order No. ҚР ДСМ-320/2020 approving the rules for pharmacovigilance and monitoring the safety, quality and effectiveness of medical devices. The official Adilet legal system lists the document as updated, including an amendment dated 26 November 2025.
• EEC Council Decision No. 87 of 3 November 2016 approving the EAEU Good Pharmacovigilance Practice Rules, as amended.
• Applicable Kazakhstan and EAEU rules on marketing authorisation, assessment and pharmaceutical inspections.

In 2024, the EEC Council introduced common approaches to pharmacovigilance-system inspections. Inspection readiness, documented processes and traceable partner oversight are therefore practical priorities for MAHs.

Core MAH requirements

Pharmacovigilance system and PSMF

The MAH should maintain an effective system and an up-to-date Pharmacovigilance System Master File (PSMF). It should cover governance, products, safety-data sources, procedures, databases, agreements, training, quality indicators, audits and corrective and preventive actions.

Qualified and local contacts

A suitably qualified pharmacovigilance person and, where required by the applicable model, an accessible Kazakhstan contact should be designated. Contact details, back-up arrangements and availability for urgent safety matters need to be documented.

ICSRs and notification cards

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

The NCEM official notification form covers suspected adverse reactions as well as overdose, abuse, lack of efficacy, use during pregnancy or breastfeeding, transmission of an infectious agent and clinically relevant interactions.

Literature and regulatory monitoring

Monitoring frequency must support timely identification and reporting of new safety information. A universal weekly requirement should not be claimed for every product without a specific legal or procedural basis. Sources, languages, search strategies, screening criteria and quality control should be documented.

PSURs, RMPs and signals

MAHs should manage periodic-reporting schedules, maintain the Risk Management Plan, assess safety signals and evaluate risk-minimisation measures. Timelines and formats depend on the type of authorisation and applicable Kazakhstan and EAEU requirements.

Inspection-readiness checklist

1. Confirm that the PSMF, SOPs and product list are current.
2. Verify responsible-person contact details and back-up coverage.
3. Reconcile safety cases with distributors and vendors.
4. Investigate overdue ICSRs and aggregate reports.
5. Update RMPs, signals and risk-minimisation measures.
6. Review training, deviations, CAPA and audit trails.
7. Ensure safety agreements define exchange timelines and responsibilities.

Conclusion

Pharmacovigilance in Kazakhstan in 2026 requires national processes to be aligned with applicable EAEU rules. MAH priorities are an operational system, a current PSMF, accessible responsible persons, timely ICSRs and periodic reports, signal management and continuous inspection readiness.

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

Official sources

1. Adilet: Order No. ҚР ДСМ-320/2020 and amendment history.
2. NCEM: pharmacovigilance rules and notification form.
3. EEC: common pharmacovigilance-system inspection rules.
4. EEC: amendments to the EAEU GVP Rules.

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