Quote from VigiServe Admin on February 4, 2026, 2:08 PM

In Kyrgyzstan (Kyrgyz Republic), the pharmacovigilance system is harmonized with the Eurasian Economic Union (EAEU). It is overseen by the Ministry of Health (Department of Pharmaceutical Supply and Medical Equipment).

1. Clinical Safety (Clinical Trials)

Clinical trials follow EAEU and ICH GCP standards.

• Expedited Reporting: Sponsors must report SUSARs (Suspected Unexpected Serious Adverse Reactions).

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Submission: Reports go directly to the Ministry of Health.

2. Post-Marketing Pharmacovigilance

Kyrgyzstan adheres to EAEU GVP (Good Pharmacovigilance Practices).

• Personnel & Infrastructure:

  • QPPV: An EAEU QPPV is mandatory (can be located in another member state). A Local Person for Pharmacovigilance (LPPV) is practically required for local compliance.

  • PSMF: Mandatory under EAEU rules.

• Incident Reporting (ICSRs):

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • PSURs: Mandatory (Frequency: 6 months initially, then annually).

  • RMPs: Mandatory for new/high-risk products.

Summary of Requirements

Component	Requirement in Kyrgyzstan
Regulatory Authority	MoH (Dept. of Pharm Supply)
Framework	EAEU GVP / Law No. 91
Local QPPV / PSMF	EAEU QPPV + LPPV / Yes
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	Russian / Kyrgyz