Pharmacovigilance Services in Kazakhstan

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Kazakhstan, explore DDReg’s pharmacovigilance services in Kazakhstan to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with the National Center for Expert Evaluation regulations, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

The National Center for Expert Evaluation of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health and Social Development is the authority responsible for pharmacovigilance in Kazakhstan.

The Code of the Republic of Kazakhstan “On People’s Health and Healthcare System” governs pharmacovigilance, safety, quality, and efficacy obligations for medicinal products and medical devices. Kazakhstan adheres to EAEU (Eurasian Economic Union) Good Pharmacovigilance Practices (GVP) via Decision No. 87 of 2016 (as amended in 2022). MAHs must comply with rules for pharmacovigilance and monitoring of safety, quality, and efficacy of medical devices.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Processing through E2B(R3)-compliant databases integrated with WHO Drug Dictionary and MedDRA
  • Quality checks, medical review, and submission within regulatory timelines
  • Maintaining monitoring and tracking sheets; reconciliation with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs / REMS per Kazakh and EAEU requirements
  • Assessing potential risks and missing information; proposing risk minimization strategies
  • Implementation of Post-Authorization Safety Studies (PASS), observational studies, targeted follow-ups
  • Effective risk communication via labeling (SmPC, patient leaflet)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
• + Signal Management
  • Identification of new safety signals from ICSRs, literature, aggregate reports, regulatory updates
  • Tools and databases for detection & tracking
  • Label update analysis; recommendations including risk minimization
• + Local PV Person Services
  • Review of PSMF, SOPs, and contracts (e.g. Safety Data Exchange Agreements)
  • Signing off on aggregate reports, signal reports, RMPs
  • Retainer services; acting as local responsible person
• + PV Quality Management, Audit & Compliance Oversight
  • Gap assessments of PV systems, staff training
  • Audit readiness, mock audits, and inspection preparation
  • Ensuring alignment with laws, EAEU regulations, SOPs