INOPP Forum
Pharmacovigilance requirements in Micronesia
Quote from VigiServe Admin on February 9, 2026, 2:37 AMFederated States of Micronesia (FSM)
The Pharmacovigilance system in FSM is effectively non-existent in terms of a functional, independent regulatory framework. There is no dedicated national PV center, legislation, or routine reporting system. Oversight is nominally under the Department of Health and Social Affairs (DHSA), but activities are limited to ad-hoc support from international bodies like the WHO Western Pacific Regional Office, primarily during vaccination campaigns.
Legal Framework and Governance
Authority: Department of Health and Social Affairs (DHSA).
Status: There is no specific pharmacovigilance legislation. Medicines regulation is minimal and falls under general public health acts.
Activity: No contribution to VigiBase. No national database exists.
Organization and Personnel
MAH Obligations: Marketing Authorization Holders have no practical local obligations.
Local Requirements: There are no requirements for a local Qualified Person for Pharmacovigilance (QPPV), Local Responsible Person, or PSMF.
Safety Reporting (Post-Marketing & Clinical Trials)
Post-Marketing: There is no mandatory reporting system. Serious ADRs are not systematically collected outside of specific humanitarian or WHO-led programs (e.g., vaccine safety).
Clinical Trials: Extremely rare. If they occur, they are managed via the DHSA or ethics committees.
Expedited Reporting: No national guidelines exist. Sponsors follow international standards (ICH E2A) in practice (typically 7 days for fatal/life-threatening, 15 days for other serious unexpected events).
Summary Table (FSM)
Feature Micronesia (FSM) Authority DHSA (Dept. of Health & Social Affairs) Maturity Non-Existent / Ad-hoc Local Person No PSMF No Serious ICSR None (Ad-hoc only) Clinical Reporting SUSARs (Intl. Practice) RMP/PSUR No
Federated States of Micronesia (FSM)
The Pharmacovigilance system in FSM is effectively non-existent in terms of a functional, independent regulatory framework. There is no dedicated national PV center, legislation, or routine reporting system. Oversight is nominally under the Department of Health and Social Affairs (DHSA), but activities are limited to ad-hoc support from international bodies like the WHO Western Pacific Regional Office, primarily during vaccination campaigns.
Legal Framework and Governance
-
Authority: Department of Health and Social Affairs (DHSA).
-
Status: There is no specific pharmacovigilance legislation. Medicines regulation is minimal and falls under general public health acts.
-
Activity: No contribution to VigiBase. No national database exists.
Organization and Personnel
-
MAH Obligations: Marketing Authorization Holders have no practical local obligations.
-
Local Requirements: There are no requirements for a local Qualified Person for Pharmacovigilance (QPPV), Local Responsible Person, or PSMF.
Safety Reporting (Post-Marketing & Clinical Trials)
-
Post-Marketing: There is no mandatory reporting system. Serious ADRs are not systematically collected outside of specific humanitarian or WHO-led programs (e.g., vaccine safety).
-
Clinical Trials: Extremely rare. If they occur, they are managed via the DHSA or ethics committees.
-
Expedited Reporting: No national guidelines exist. Sponsors follow international standards (ICH E2A) in practice (typically 7 days for fatal/life-threatening, 15 days for other serious unexpected events).
-
Summary Table (FSM)
| Feature | Micronesia (FSM) |
| Authority | DHSA (Dept. of Health & Social Affairs) |
| Maturity | Non-Existent / Ad-hoc |
| Local Person | No |
| PSMF | No |
| Serious ICSR | None (Ad-hoc only) |
| Clinical Reporting | SUSARs (Intl. Practice) |
| RMP/PSUR | No |