INOPP Forum
Pharmacovigilance requirements in Seychelles
Quote from VigiServe Admin on February 9, 2026, 2:42 AMSeychelles operates a basic, developing pharmacovigilance system overseen by the Ministry of Health (Pharmaceutical Services / Medicines Regulatory Unit). While the system is small, it serves the specific needs of the island nation's population and relies on WHO norms. Seychelles is a full member of the WHO Programme for International Drug Monitoring (joined 2012).
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare in Seychelles.
Regulatory Oversight: Any clinical research requires approval from the Ministry of Health and the relevant Ethics Committee.
Safety Reporting: In the absence of specific national trial regulations, sponsors are expected to follow ICH E2A standards.
SUSARs: Expedited reporting (typically 7 days for fatal/life-threatening, 15 days for other serious).
Submission: Direct submission to the Ministry of Health.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is centralized under the Ministry of Health.
Governance: The Medicines Regulatory Unit (under Pharmaceutical Services) handles regulatory affairs, including safety monitoring.
Regional Alignment: Unlike the user's prompt text (which likely referenced Caribbean standards by mistake), Seychelles is an African Union / SADC member state and aligns with WHO Africa standards, not CARPHA.
Personnel & Infrastructure:
Local Person: No mandatory "Qualified Person for Pharmacovigilance" (QPPV) in the European sense. Liaison is typically handled by the local importer or distributor.
PSMF: Not required.
Incident Reporting (ICSRs):
Method: Spontaneous reporting from healthcare professionals (HCPs) at Seychelles Hospital and public clinics.
Database: Seychelles contributes to VigiBase (WHO global database).
Timelines: "Prompt" reporting of serious issues is the standard expectation.
Risk & Periodic Reporting:
PSURs/RMPs: Not routinely required for market authorization; requested only for specific safety concerns.
Summary of Requirements
Component Requirement in Seychelles Regulatory Authority Ministry of Health (Pharmaceutical Services) Maturity Basic / Developing Local Person No (Importer handles liaison) PSMF No Serious ICSR Prompt (Ad-hoc) Clinical Reporting SUSARs (Intl. Practice) RMP/PSUR No
Seychelles operates a basic, developing pharmacovigilance system overseen by the Ministry of Health (Pharmaceutical Services / Medicines Regulatory Unit). While the system is small, it serves the specific needs of the island nation's population and relies on WHO norms. Seychelles is a full member of the WHO Programme for International Drug Monitoring (joined 2012).
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare in Seychelles.
-
Regulatory Oversight: Any clinical research requires approval from the Ministry of Health and the relevant Ethics Committee.
-
Safety Reporting: In the absence of specific national trial regulations, sponsors are expected to follow ICH E2A standards.
-
SUSARs: Expedited reporting (typically 7 days for fatal/life-threatening, 15 days for other serious).
-
Submission: Direct submission to the Ministry of Health.
-
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is centralized under the Ministry of Health.
-
Governance: The Medicines Regulatory Unit (under Pharmaceutical Services) handles regulatory affairs, including safety monitoring.
-
Regional Alignment: Unlike the user's prompt text (which likely referenced Caribbean standards by mistake), Seychelles is an African Union / SADC member state and aligns with WHO Africa standards, not CARPHA.
-
Personnel & Infrastructure:
-
Local Person: No mandatory "Qualified Person for Pharmacovigilance" (QPPV) in the European sense. Liaison is typically handled by the local importer or distributor.
-
PSMF: Not required.
-
-
Incident Reporting (ICSRs):
-
Method: Spontaneous reporting from healthcare professionals (HCPs) at Seychelles Hospital and public clinics.
-
Database: Seychelles contributes to VigiBase (WHO global database).
-
Timelines: "Prompt" reporting of serious issues is the standard expectation.
-
-
Risk & Periodic Reporting:
-
PSURs/RMPs: Not routinely required for market authorization; requested only for specific safety concerns.
-
Summary of Requirements
| Component | Requirement in Seychelles |
| Regulatory Authority | Ministry of Health (Pharmaceutical Services) |
| Maturity | Basic / Developing |
| Local Person | No (Importer handles liaison) |
| PSMF | No |
| Serious ICSR | Prompt (Ad-hoc) |
| Clinical Reporting | SUSARs (Intl. Practice) |
| RMP/PSUR | No |