Algeria has introduced a new regulatory framework governing pharmaceutical exploitation establishments, marking a significant step toward modernizing its healthcare and pharmaceutical sectors. Issued under Ministerial Decree No. 23 on October 1, 2025, this updated framework replaces the previous decree from November 14, 2021, and sets forth clearer, more rigorous standards for obtaining authorization to operate within the pharmaceutical domain. The decree outlines the essential components required in application files, including detailed technical documentation, quality assurance protocols, and evidence of compliance with national safety and efficacy standards.
The new framework also streamlines the approval process by establishing defined timelines for application review, transparent evaluation criteria, and procedures for handling substantial modifications to previously authorized establishments. Pharmaceutical entities must now adhere to stricter documentation and reporting obligations, ensuring that their operations align with Algeria’s public health priorities and international regulatory benchmarks. This shift reflects the government’s commitment to enhancing oversight, improving the quality of medical products, and fostering a more competitive and accountable pharmaceutical industry.
In addition to procedural reforms, the decree emphasizes transparency and traceability, requiring establishments to maintain comprehensive records and submit regular updates to the Ministry of Industry and Pharmaceutical Production. These measures are designed to reinforce regulatory integrity and support Algeria’s broader efforts to digitize and modernize its pharmaceutical infrastructure. The decree complements recent initiatives by the Algerian National Agency of Pharmaceutical Products, such as the adoption of the Common Technical Document format for drug registration and the rollout of digital platforms for managing submissions and approvals.
Pharmaceutical companies operating in Algeria are now urged to reassess their compliance status and update their authorization files to meet the new requirements. Failure to do so may result in delays or rejection of applications, potentially impacting market access and operational continuity. As Algeria continues to reform its healthcare and regulatory systems, this decree represents a pivotal move toward ensuring the safety, efficiency, and transparency of pharmaceutical exploitation, ultimately contributing to better health outcomes and a more resilient medical supply chain.