INOPP Forum
Pharmacovigilance Requirements in Guinea
Quote from VigiServe Admin on February 8, 2026, 8:02 AMIn Guinea, Pharmacovigilance is regulated by the Direction Nationale de la Pharmacie et du Médicament (DNPM) under the Ministry of Health. The system is governed by Law L/2018/024/AN (2018) and the 2023 Pharmacovigilance Guidelines. It is a decentralized structure involving a National Pharmacovigilance Commission and Technical Committee.
1. Clinical Safety (Clinical Trials)
Clinical trials require authorization from the DNPM and adherence to international ethical norms.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While the system is developing, it aligns with ICH E2A norms:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are typically required annually or upon request.
Submission: Reports are submitted directly to the DNPM via email or forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic but features stricter written timelines for serious cases compared to many neighbors, per the 2023 guidelines.
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Guinea.
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in the country.
Incident Reporting (ICSRs):
Serious/Unexpected: Must be reported within 24 to 48 hours.
Deaths: Must be reported within 24 hours.
Non-Serious: Reported within 90 days.
Risk & Periodic Reporting:
PSURs: Not routinely mandatory. Updates may be requested during registration renewal.
RMPs: Not a standard requirement; risk assessment is reactive.
Summary of Requirements
Component Requirement in Guinea Regulatory Authority DNPM (Direction Nationale de la Pharmacie) Framework Law L/2018 + 2023 Guidelines Local QPPV / PSMF Not required Serious ICSR Timeline 24–48 Hours (Strict) Clinical Reporting SUSARs (Expedited); DSURs (on request) Regional Alignment WHO / West Africa
In Guinea, Pharmacovigilance is regulated by the Direction Nationale de la Pharmacie et du Médicament (DNPM) under the Ministry of Health. The system is governed by Law L/2018/024/AN (2018) and the 2023 Pharmacovigilance Guidelines. It is a decentralized structure involving a National Pharmacovigilance Commission and Technical Committee.
1. Clinical Safety (Clinical Trials)
Clinical trials require authorization from the DNPM and adherence to international ethical norms.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While the system is developing, it aligns with ICH E2A norms:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are typically required annually or upon request.
-
Submission: Reports are submitted directly to the DNPM via email or forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic but features stricter written timelines for serious cases compared to many neighbors, per the 2023 guidelines.
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Guinea.
-
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in the country.
-
-
Incident Reporting (ICSRs):
-
Serious/Unexpected: Must be reported within 24 to 48 hours.
-
Deaths: Must be reported within 24 hours.
-
Non-Serious: Reported within 90 days.
-
-
Risk & Periodic Reporting:
-
PSURs: Not routinely mandatory. Updates may be requested during registration renewal.
-
RMPs: Not a standard requirement; risk assessment is reactive.
-
Summary of Requirements
| Component | Requirement in Guinea |
| Regulatory Authority | DNPM (Direction Nationale de la Pharmacie) |
| Framework | Law L/2018 + 2023 Guidelines |
| Local QPPV / PSMF | Not required |
| Serious ICSR Timeline | 24–48 Hours (Strict) |
| Clinical Reporting | SUSARs (Expedited); DSURs (on request) |
| Regional Alignment | WHO / West Africa |