INOPP Forum
Pharmacovigilance Requirements in Moldova
Quote from VigiServe Admin on January 17, 2021, 8:23 AMIn Moldova, Pharmacovigilance is regulated by the State Agency on Medicines and Medical Devices (AMDM). As an EU candidate country, the system is robust and actively harmonizing with EU Good Pharmacovigilance Practices (GVP).
1. Clinical Safety (Clinical Trials)
Clinical trials require AMDM approval and adherence to ICH GCP and EU-aligned principles.
Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the AMDM:
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, monitoring, and communication with the AMDM and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval requirements are strict, reflecting the country's EU integration efforts.
Personnel:
Qualified Person (QPPV): Mandatory. Must be a qualified physician or pharmacist.
Local Contact Person: Mandatory if the QPPV is not resident in Moldova. This person acts as the primary liaison with the AMDM.
Documentation: A Pharmacovigilance System Master File (PSMF) is required (EU Module II aligned). It does not need to be registered but must be maintained and available for inspection.
Incident Reporting (ICSRs):
Serious (Unexpected/Expected): Report within 15 calendar days.
Non-Serious: Report within 90 calendar days.
Foreign Cases: Serious unexpected cases relevant to benefit-risk reported within 15 days.
Risk & Periodic Reporting:
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months for the first 2 years, then annually.
Risk Management Plans (RMPs): Mandatory for new active substances, biologics, and high-risk products (EU GVP V aligned).
Additional Monitoring: The Black Triangle (▼) scheme is implemented for high-risk medicines.
Summary of Requirements
Component Requirement in Moldova Regulatory Authority AMDM (State Agency on Medicines and Medical Devices) Personnel QPPV (Mandatory) + Local Contact (if QPPV is foreign) PSMF Required (Maintained locally or accessible) SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs & PSURs Mandatory (EU-aligned) Special Monitoring Black Triangle (▼) scheme in place
In Moldova, Pharmacovigilance is regulated by the State Agency on Medicines and Medical Devices (AMDM). As an EU candidate country, the system is robust and actively harmonizing with EU Good Pharmacovigilance Practices (GVP).
1. Clinical Safety (Clinical Trials)
Clinical trials require AMDM approval and adherence to ICH GCP and EU-aligned principles.
-
Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the AMDM:
-
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, monitoring, and communication with the AMDM and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval requirements are strict, reflecting the country's EU integration efforts.
-
Personnel:
-
Qualified Person (QPPV): Mandatory. Must be a qualified physician or pharmacist.
-
Local Contact Person: Mandatory if the QPPV is not resident in Moldova. This person acts as the primary liaison with the AMDM.
-
-
Documentation: A Pharmacovigilance System Master File (PSMF) is required (EU Module II aligned). It does not need to be registered but must be maintained and available for inspection.
-
Incident Reporting (ICSRs):
-
Serious (Unexpected/Expected): Report within 15 calendar days.
-
Non-Serious: Report within 90 calendar days.
-
Foreign Cases: Serious unexpected cases relevant to benefit-risk reported within 15 days.
-
-
Risk & Periodic Reporting:
-
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months for the first 2 years, then annually.
-
Risk Management Plans (RMPs): Mandatory for new active substances, biologics, and high-risk products (EU GVP V aligned).
-
Additional Monitoring: The Black Triangle (▼) scheme is implemented for high-risk medicines.
-
Summary of Requirements
| Component | Requirement in Moldova |
| Regulatory Authority | AMDM (State Agency on Medicines and Medical Devices) |
| Personnel | QPPV (Mandatory) + Local Contact (if QPPV is foreign) |
| PSMF | Required (Maintained locally or accessible) |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs & PSURs | Mandatory (EU-aligned) |
| Special Monitoring | Black Triangle (▼) scheme in place |