Quote from VigiServe Admin on February 9, 2026, 2:31 AM

1. Democratic Republic of the Congo (DRC)

(Also known as Congo-Kinshasa)

The PV system in the DRC is developing and functional, overseen by the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP) and the Direction de la Pharmacie et du Médicament (DPM). The Centre National de Pharmacovigilance (CNPV) is established at the University of Kinshasa and coordinates safety monitoring.

Legal Framework and Governance

• Authority: ACOREP (under the Ministry of Public Health, Hygiene and Prevention).

• Key Regulations: Ministerial Orders (e.g., No. 1250 series) and the National Pharmacovigilance Guidelines.

• System: ACOREP evaluates risks; CNPV collects and analyzes data. The system is decentralized with provincial focal points but centralized analysis.

Organization and Personnel

• MAH Obligations: MAHs must monitor the safety of their products.

• Local Person: While a "Qualified Person for Pharmacovigilance" (QPPV) title is not strictly codified in the same way as the EU, a local representative or responsible person is required for regulatory liaison and safety communication.

• PSMF: Not explicitly mandatory to register, but a description of the PV system is often required during market authorization.

Individual Case Safety Reports (ICSRs) – Post-Marketing

• Reporting: MAHs must report suspected ADRs to the CNPV/ACOREP.

• Timelines:

  • Serious/Unexpected: Expedited reporting is required (Guidelines align with WHO norms, typically 15 calendar days).

  • Non-Serious: Reported periodically or upon request.

• Submission: Paper-based or email; integration with VigiFlow is in progress/used by CNPV.

Clinical Trials-Related Safety Requirements

• Approval: Clinical trials require authorization from ACOREP and the National Ethics Committee (CNES).

• Expedited Reporting: Sponsors must report SUSARs (Suspected Unexpected Serious Adverse Reactions) to ACOREP and the Ethics Committee.

  • Fatal/Life-Threatening: Typically 7 calendar days.

  • Other Serious Unexpected: Typically 15 calendar days.

• Periodic Reporting: Annual safety reports or DSURs are required.

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2. Republic of the Congo

(Also known as Congo-Brazzaville)

The PV system here is emerging and basic. Oversight is provided by the Direction de la Pharmacie et du Médicament (DPM), but a fully operational national PV center with strict enforcement is still in development.

Legal Framework and Governance

• Authority: Direction de la Pharmacie et du Médicament (DPM).

• Status: The country follows WHO minimum standards but lacks a comprehensive, standalone national GVP law with rigid enforcement mechanisms.

• Activity: Routine submission to international databases (VigiBase) is limited/intermittent.

Organization and Personnel

• MAH Obligations: Basic requirement to ensure product safety.

• Local Requirements: No mandatory requirement for a dedicated local QPPV or PSMF registration is strictly enforced in public guidelines. Reliance is on the local authorized distributor/agent for communication.

Safety Reporting (Post-Marketing & Clinical Trials)

• Post-Marketing: Reporting is spontaneous and ad-hoc. There are no rigidly enforced timelines (e.g., 15 days) in the regulations, but "prompt" reporting of serious issues is the expectation.

• Clinical Trials: Rare. When they occur, they follow international ICH-GCP standards. Safety reports are submitted directly to the Ministry of Health or the institutional ethics committee.

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Summary Table (Both Congos)

Feature	Dem. Rep. of Congo (DRC)	Republic of the Congo
Authority	ACOREP / CNPV	DPM
Maturity	Functional / Developing	Basic / Emerging
Local Person	Local Representative (Practice)	No
PSMF	Docs Required (Registration)	No
Serious ICSR	15 Days (Guideline)	Ad-hoc ("Prompt")
Clinical Reporting	SUSARs (7/15 Days)	SUSARs (Intl. Norms)
RMP/PSUR	High Risk Only	No