INOPP Forum
Pharmacovigilance requirements in Comoros
Quote from VigiServe Admin on February 10, 2026, 10:25 AMIn Comoros, the pharmacovigilance system is largely non-functional. There is no modern legal framework, national center, or active membership in the WHO PIDM. Activities are limited to ad-hoc support from WHO and NGOs, particularly during vaccination campaigns.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian or NGO-driven.
Framework: No national guidelines; sponsors follow international standards (ICH E2A).
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs as a matter of best practice.
Submission: Reports go directly to the Ministry of Health (MoH).
2. Post-Marketing Pharmacovigilance
There are no enforceable local obligations for Marketing Authorization Holders.
Personnel & Infrastructure:
No Local QPPV: Not required.
No PSMF Mandate: Not required.
Incident Reporting (ICSRs):
Enforcement: Voluntary/Ad-hoc.
Practice: Reporting is negligible outside of specific campaigns; serious ADRs are handled ad-hoc.
Risk & Periodic Reporting:
PSURs/RMPs: Not required.
Summary of Requirements
Component Requirement in Comoros Regulatory Authority MoH (Ministère de la Santé) Framework Non-functional / Ad-hoc Local QPPV / PSMF Not required Safety Reporting None / Ad-hoc Clinical Reporting SUSARs (7/15 days - International practice) Submission Language French
In Comoros, the pharmacovigilance system is largely non-functional. There is no modern legal framework, national center, or active membership in the WHO PIDM. Activities are limited to ad-hoc support from WHO and NGOs, particularly during vaccination campaigns.
1. Clinical Safety (Clinical Trials)
Clinical trials are extremely rare and typically humanitarian or NGO-driven.
-
Framework: No national guidelines; sponsors follow international standards (ICH E2A).
-
Expedited Reporting: Sponsors generally follow 7 days (fatal/life-threatening) and 15 days (other serious unexpected) for SUSARs as a matter of best practice.
-
Submission: Reports go directly to the Ministry of Health (MoH).
2. Post-Marketing Pharmacovigilance
There are no enforceable local obligations for Marketing Authorization Holders.
-
Personnel & Infrastructure:
-
No Local QPPV: Not required.
-
No PSMF Mandate: Not required.
-
-
Incident Reporting (ICSRs):
-
Enforcement: Voluntary/Ad-hoc.
-
Practice: Reporting is negligible outside of specific campaigns; serious ADRs are handled ad-hoc.
-
-
Risk & Periodic Reporting:
-
PSURs/RMPs: Not required.
-
Summary of Requirements
| Component | Requirement in Comoros |
| Regulatory Authority | MoH (Ministère de la Santé) |
| Framework | Non-functional / Ad-hoc |
| Local QPPV / PSMF | Not required |
| Safety Reporting | None / Ad-hoc |
| Clinical Reporting | SUSARs (7/15 days - International practice) |
| Submission Language | French |