Algeria: ANPP Publishes an Updated Guide on Good Pharmacovigilance Practices (Version 2)
Publication date: 19 January 2026
The National Agency for Pharmaceutical Products (ANPP) of Algeria has published an updated version of the Guide on Good Pharmacovigilance Practices (GVP) on 19 January 2026. This new version (Version 2) replaces the previous guidance and aims to further strengthen the national pharmacovigilance system in line with international standards.
This update applies to all pharmaceutical establishments involved in the manufacture, importation, marketing, and distribution of medicinal products for human use in Algeria.
Regulatory Context and Objectives of the Update
The updated Algerian GVP Guide has been developed to:
Reinforce the safety monitoring of medicinal products throughout their lifecycle;
Clarify the roles and responsibilities of marketing authorization holders (MAHs) and other stakeholders;
Improve the quality, consistency, and traceability of pharmacovigilance activities;
Align national practices more closely with international pharmacovigilance principles, including those promoted by the World Health Organization (WHO).
Through this revision, the ANPP confirms its commitment to protecting public health and enhancing regulatory oversight of medicinal product safety.
Scope of Application
The updated guide applies to:
Marketing Authorization Holders (MAHs);
Pharmaceutical manufacturers and importers;
Distributors and other entities involved in the supply of medicinal products in Algeria.
All concerned stakeholders are required to ensure that their pharmacovigilance systems are implemented, documented, and maintained in accordance with the revised requirements.
Key Principles Reinforced in Version 2
The updated guide emphasizes several core pharmacovigilance principles, including:
The establishment and maintenance of an effective pharmacovigilance system;
Clear designation of responsibilities for pharmacovigilance oversight;
Timely collection, evaluation, and reporting of adverse drug reactions;
Proper documentation, archiving, and traceability of pharmacovigilance data;
Continuous quality improvement and compliance monitoring of vigilance activities.
These principles aim to ensure the early detection, assessment, and prevention of risks associated with the use of medicinal products.
Operational Impact for Pharmaceutical Companies
The publication of Version 2 of the Algerian GVP Guide may require pharmaceutical companies to:
Review and update their pharmacovigilance procedures and SOPs;
Assess the adequacy of their local pharmacovigilance organization;
Ensure staff are adequately trained on updated requirements;
Strengthen internal controls related to signal detection, reporting timelines, and documentation;
Prepare for potential inspections or regulatory audits by the ANPP.
Proactive alignment with the updated guide is essential to maintain regulatory compliance and avoid enforcement actions.
A Step Forward for Patient Safety in Algeria
By updating its Good Pharmacovigilance Practices Guide, the ANPP contributes to a more robust, transparent, and effective national pharmacovigilance framework. This regulatory evolution supports safer use of medicines and reinforces trust in the Algerian pharmaceutical regulatory system.
Conclusion and Regulatory Support Services
The update of the Algerian Good Pharmacovigilance Practices Guide (Version 2) represents a significant regulatory milestone for pharmaceutical operators active in Algeria. Early assessment of the impact on existing pharmacovigilance systems is key to ensuring compliance and operational continuity.
Simon MedTech Solutions supports pharmaceutical companies with:
Gap analysis against Algerian GVP requirements (Version 2);
Update and alignment of pharmacovigilance SOPs and systems;
Support in preparing for ANPP inspections and audits;
Regulatory intelligence and ongoing monitoring of pharmacovigilance updates in North Africa.
Contact us to ensure your pharmacovigilance activities remain compliant with the latest ANPP regulatory requirements.
