Algeria

Pharmacovigilance in Algeria is implemented through the national system involving the Centre National de Pharmacovigilance et de Matériovigilance (CNPM) and the Agence Nationale des Produits Pharmaceutiques (ANPP). The current national framework is the Guide Algérien de Bonnes Pratiques de Pharmacovigilance, Version 2.0 (19 January 2026), which replaces the previous version and is supplemented by ANPP implementation notes issued in 2026. Holders/operators must establish a quality-managed pharmacovigilance system, appoint the required full-time QPPV and, where applicable, a local pharmacovigilance representative, maintain an accessible PSMF and meet ICSR, PBRER, RMP, signal-management, audit and inspection requirements. Serious valid ICSRs are generally reported within 15 days and non-serious cases within 90 days, subject to shorter timelines for specified access programmes; PBRER submission follows the applicable 70/90-day timelines. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.