INOPP Forum
Pharmacovigilance requirements in Tajikistan
Quote from VigiServe Admin on February 8, 2026, 1:50 AMIn Tajikistan, Pharmacovigilance is overseen by the Ministry of Health and Social Protection of the Population (MoHSP) through the Agency for State Supervision of Pharmaceutical Activities. The system is harmonized with the Eurasian Economic Union (EAEU) Good Pharmacovigilance Practices (GVP), adhering to the same rigid standards found in Russia and Kazakhstan (Decision No. 87 of 2016).
1. Clinical Safety (Clinical Trials)
Safety monitoring during clinical trials is strictly regulated, aligning with ICH GCP and EAEU principles.
Approvals: Trials require authorization from the MoHSP/Agency.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) according to international timelines:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
Oversight: Sponsors are responsible for causality assessment and communication with the Agency and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval requirements are structured around EAEU compliance, necessitating both regional and local oversight.
Personnel:
EAEU Qualified Person (QPPV): Mandatory. Must be a resident of the EAEU region (often based in Russia/Kazakhstan) with a medical/pharmaceutical degree.
Local Person for Pharmacovigilance (LPPV): Expected/Practically Required. The national authority typically requests a local resident contact to handle reporting and compliance if the QPPV is located abroad.
Documentation: A Pharmacovigilance System Master File (PSMF) is required per EAEU GVP and must be available for inspection.
Incident Reporting (ICSRs):
Serious Cases (Domestic/Unexpected): Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Foreign Serious Unexpected: Report within 15 calendar days if relevant.
Periodic Reporting (PSURs):
Frequency: Every 6 months (first 2 years) → Annually (next 2 years) → Every 5 years (thereafter).
Format: ICH E2C(R2).
Risk Management Plans (RMPs): Mandatory for new active substances, biologics, and high-risk products (EAEU GVP Module V).
Summary of Requirements
Component Requirement in Tajikistan Regulatory Authority MoHSP / Agency for State Supervision of Pharmaceutical Activities Regional Framework Eurasian Economic Union (EAEU) GVP QPPV Requirements EAEU QPPV (Mandatory) + Local Person (Expected) PSMF Required (EAEU standard) SUSAR Reporting 7 days (fatal) / 15 days (other serious) PSUR Frequency 6 months (first 2 yrs) → Annual (next 2 yrs) → 5 years
In Tajikistan, Pharmacovigilance is overseen by the Ministry of Health and Social Protection of the Population (MoHSP) through the Agency for State Supervision of Pharmaceutical Activities. The system is harmonized with the Eurasian Economic Union (EAEU) Good Pharmacovigilance Practices (GVP), adhering to the same rigid standards found in Russia and Kazakhstan (Decision No. 87 of 2016).
1. Clinical Safety (Clinical Trials)
Safety monitoring during clinical trials is strictly regulated, aligning with ICH GCP and EAEU principles.
-
Approvals: Trials require authorization from the MoHSP/Agency.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) according to international timelines:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).
-
Oversight: Sponsors are responsible for causality assessment and communication with the Agency and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval requirements are structured around EAEU compliance, necessitating both regional and local oversight.
-
Personnel:
-
EAEU Qualified Person (QPPV): Mandatory. Must be a resident of the EAEU region (often based in Russia/Kazakhstan) with a medical/pharmaceutical degree.
-
Local Person for Pharmacovigilance (LPPV): Expected/Practically Required. The national authority typically requests a local resident contact to handle reporting and compliance if the QPPV is located abroad.
-
-
Documentation: A Pharmacovigilance System Master File (PSMF) is required per EAEU GVP and must be available for inspection.
-
Incident Reporting (ICSRs):
-
Serious Cases (Domestic/Unexpected): Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
Foreign Serious Unexpected: Report within 15 calendar days if relevant.
-
-
Periodic Reporting (PSURs):
-
Frequency: Every 6 months (first 2 years) → Annually (next 2 years) → Every 5 years (thereafter).
-
Format: ICH E2C(R2).
-
-
Risk Management Plans (RMPs): Mandatory for new active substances, biologics, and high-risk products (EAEU GVP Module V).
Summary of Requirements
| Component | Requirement in Tajikistan |
| Regulatory Authority | MoHSP / Agency for State Supervision of Pharmaceutical Activities |
| Regional Framework | Eurasian Economic Union (EAEU) GVP |
| QPPV Requirements | EAEU QPPV (Mandatory) + Local Person (Expected) |
| PSMF | Required (EAEU standard) |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| PSUR Frequency | 6 months (first 2 yrs) → Annual (next 2 yrs) → 5 years |