INOPP Forum
Pharmacovigilance requirements in Haiti
Quote from VigiServe Admin on February 9, 2026, 2:48 AMThe Pharmacovigilance system in Haiti is effectively non-existent in terms of a functional, independent regulatory framework. The country faces significant infrastructure challenges, and there is no operational national pharmacovigilance center. Oversight nominally falls under the Ministry of Public Health and Population (MSPP), specifically the Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (DPM/MT).
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and are typically driven by international research institutes or humanitarian organizations (e.g., for vaccines or infectious diseases).
Approvals: Authorization is required from the MSPP and the National Bioethics Committee (CNBH).
Expedited Reporting: There are no codified national guidelines. In practice, international sponsors follow ICH E2A standards:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Submission: Reports are submitted directly to the MSPP or the Ethics Committee; there is no specific safety unit to process them.
2. Post-Marketing Pharmacovigilance
There are no practical local obligations for Marketing Authorization Holders. The system relies entirely on external humanitarian aid and WHO support during health emergencies.
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance.
No PSMF Mandate: Not required.
Incident Reporting (ICSRs):
Enforcement: None. There are no mandatory forms, databases, or timelines.
Practice: Reporting is ad-hoc and spontaneous, usually occurring only within specific NGO-led programs (e.g., during cholera outbreaks or vaccination campaigns).
Risk & Periodic Reporting:
PSURs/RMPs: Not required or enforced.
Summary Table (Haiti)
Feature Haiti Authority MSPP (Ministry of Public Health) Maturity Non-Existent / Ad-hoc Local Person No PSMF No Serious ICSR None (Ad-hoc only) Clinical Reporting SUSARs (Intl. Practice) RMP/PSUR No
The Pharmacovigilance system in Haiti is effectively non-existent in terms of a functional, independent regulatory framework. The country faces significant infrastructure challenges, and there is no operational national pharmacovigilance center. Oversight nominally falls under the Ministry of Public Health and Population (MSPP), specifically the Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (DPM/MT).
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and are typically driven by international research institutes or humanitarian organizations (e.g., for vaccines or infectious diseases).
-
Approvals: Authorization is required from the MSPP and the National Bioethics Committee (CNBH).
-
Expedited Reporting: There are no codified national guidelines. In practice, international sponsors follow ICH E2A standards:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Submission: Reports are submitted directly to the MSPP or the Ethics Committee; there is no specific safety unit to process them.
2. Post-Marketing Pharmacovigilance
There are no practical local obligations for Marketing Authorization Holders. The system relies entirely on external humanitarian aid and WHO support during health emergencies.
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance.
-
No PSMF Mandate: Not required.
-
-
Incident Reporting (ICSRs):
-
Enforcement: None. There are no mandatory forms, databases, or timelines.
-
Practice: Reporting is ad-hoc and spontaneous, usually occurring only within specific NGO-led programs (e.g., during cholera outbreaks or vaccination campaigns).
-
-
Risk & Periodic Reporting:
-
PSURs/RMPs: Not required or enforced.
-
Summary Table (Haiti)
| Feature | Haiti |
| Authority | MSPP (Ministry of Public Health) |
| Maturity | Non-Existent / Ad-hoc |
| Local Person | No |
| PSMF | No |
| Serious ICSR | None (Ad-hoc only) |
| Clinical Reporting | SUSARs (Intl. Practice) |
| RMP/PSUR | No |