The final version of the Pharmacovigilance Good Practice Guide is now available.
Following a public consultation period (until October 15, 2025), the Algerian Ministry of Health, Ministry of Pharmaceutical Industry, the National Pharmacovigilance and Materiovigilance Centre (CNPM), and the National Agency for Pharmaceutical Products (ANPP) have jointly issued the final Algerian Guide to Good Pharmacovigilance Practices (BPPV) – Version 2.0, December 2025.
This document is the official regulatory framework, replacing all previous versions. It harmonizes national practices with international standards (EU Good Pharmacovigilance Practices – GVP & ICH guidelines) while addressing the specificities of the Algerian healthcare system, as mandated by the inter-ministerial decree of September 10, 2025.
Detailed Medical & Regulatory Content Overview
1. Scope and Applicability
- Applies to: All stakeholders in the lifecycle of human-use pharmaceutical products in Algeria.
- Key Stakeholders: Marketing Authorization Holders (MAHs) / Decision Holders (Détenteurs de la Décision d’Enregistrement – DE), healthcare professionals (doctors, pharmacists, nurses), public/private healthcare institutions, patients, patient associations, clinical trial sponsors, ethics committees, and national health authorities (CNPM, ANPP).
- Covered Activities: Detection, collection, assessment, and monitoring of Adverse Drug Reactions (ADRs); risk management; submission of safety reports (ICSRs, PSURs/PBRERs); safety communication; and implementation of risk minimization measures.
2. The National Pharmacovigilance System
- Central Authority: The CNPM is the central administrative body responsible for collecting, analyzing, and evaluating ADR reports, detecting safety signals, and assessing Risk Management Plans (RMPs).
- Regulatory Authority: The ANPP is responsible for product regulation, inspection, audit, and taking regulatory actions (e.g., suspension, withdrawal) based on CNPM assessments.
- Reporting Obligations: All healthcare professionals are legally obligated to report any suspected ADR (serious/non-serious, expected/unexpected) and other issues like medication errors, lack of efficacy (especially for vaccines), and suspected quality defects to the CNPM.
- Patient Reporting: Patients and caregivers are encouraged to report ADRs directly to the CNPM via various channels (forms, website, mobile app).
3. Core Pharmacovigilance Processes & Requirements for MAHs
a) Quality System
- MAHs must establish and maintain a robust, documented quality system for all PV activities.
- Principles include patient focus, management leadership, staff competence, and continuous improvement.
b) Pharmacovigilance System Master File (PSMF)
- Mandatory Requirement: Every MAH must create, maintain, and have readily available upon request a PSMF that describes their global and Algeria-specific PV system.
- Location: The PSMF must be located either at the site of the main PV activities or at the site of the Qualified Person for Pharmacovigilance (QPPV). For multinational companies, a global PSMF and a national addendum (Presentation Algérienne) describing local activities are required.
- Content: Must include detailed sections on the QPPV, organizational structure, safety data sources, IT systems, PV processes, system performance, and the quality system.
c) Qualified Person for Pharmacovigilance (QPPV) / Local PV Representative (RLPV)
- Mandatory Appointment: MAHs must permanently have a QPPV (for local companies) or an RLPV (for multinationals) residing in Algeria.
- Qualifications: Must be a Pharmacist or Doctor of Pharmacy with at least two years of PV experience (with a 2-year transitional period for training-based qualification).
- Role: Acts as the single 24/7 point of contact for the ANPP/CNPM. Responsible for the PV system, has oversight of safety profiles, and must have sufficient authority and access to all relevant safety information, including the PSMF and safety database.
d) Individual Case Safety Reports (ICSRs)
- MAHs are responsible for collecting and compiling all suspected ADR reports from any source.
- ICSRs must be submitted to the CNPM in compliance with international standards (ICH E2B).
- Clear timelines and procedures for case management, follow-up, and quality control are mandated.
e) Risk Management Plan (RMP) / Plan de Gestion des Risques (PGR)
- Requirement: An RMP must be submitted with all new Marketing Authorization Applications (MAAs), renewals, and variations involving significant changes.
- Content: Based on the EU model, it must include:
- Safety Specification: Epidemiology, identified/potential important risks, and missing information.
- Pharmacovigilance Plan: Routine and additional activities to characterize risks.
- Risk Minimization Plan: Routine measures (SmPC, labeling) and, if needed, additional tools (educational materials, controlled access programs, DHPCs).
- For Multinationals: Companies with a European/Global RMP must submit it alongside an “Algerian Presentation” of the RMP, highlighting alignment and justifying any local adaptations or differences.
f) Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
- MAHs must submit PSURs/PBRERs at defined frequencies to evaluate the ongoing benefit-risk balance of their products.
g) Post-Authorization Safety Studies (PASS)
- Requirements and procedures for conducting imposed or non-imposed safety studies are outlined, including protocol submission and communication of results.
4. Inspections & Audits
- The ANPP has the authority to conduct PV inspections at MAH premises or contracted service providers, both in Algeria and abroad.
- Types: Routine system/product inspections, “for-cause” inspections (triggered by specific issues), and re-inspections.
- Focus: Compliance with PV obligations, quality systems, PSMF accuracy, ICSR reporting timeliness, and RMP implementation.
- Outcome: Non-compliance can lead to corrective action plans and regulatory sanctions.
5. Signal Management & Safety Communication
- Defines processes for signal detection, validation, prioritization, and assessment by both MAHs and the CNPM.
- Outlines methods for safety communication: Direct Healthcare Professional Communications (DHPCs), public announcements, websites, and bulletins. All DHPCs and educational materials require prior approval from the CNPM.
6. Additional Monitoring & Risk Minimization Measures
- Products may be subject to additional monitoring (denoted by a black inverted triangle), encouraging heightened reporting.
- Detailed guidance is provided on selecting and assessing the effectiveness of additional risk minimization measures (e.g., educational programs, pregnancy prevention programs).
Key Regulatory Implications & Takeaways
- Legally Binding: This Guide is the official regulatory text enforcing PV requirements in Algeria.
- Harmonization with Stringent Local Requirements: While aligned with EU GVP, Algerian authorities retain the right to impose additional local requirements. Multinational companies cannot assume full EU compliance is sufficient.
- Critical Local Roles: The appointment of a resident, empowered, and experienced RLPV/QPPV and the maintenance of an accessible, inspection-ready PSMF are fundamental compliance pillars.
- Proactive Risk Management: The emphasis on RMPs, signal management, and effectiveness assessment of risk minimization measures requires MAHs to adopt a proactive, lifecycle approach to product safety.
- Enforcement Power: The detailed inspection and audit chapter underscores the ANPP’s active oversight role, with the power to impose sanctions for non-compliance.
- Transitional Periods: Note is made of transitional arrangements (e.g., for QPPV/RLPV experience requirements), but companies must plan for full compliance promptly.
Conclusion: The publication of the final Algerian BPPV Guide marks a significant maturation of the national pharmacovigilance framework. It sets clear, stringent, and internationally harmonized expectations for all stakeholders, with a strong focus on patient safety, robust quality systems, and transparent communication. Marketing Authorization Holders must urgently review their systems, processes, and local resources to ensure full compliance.
