The Ministry of Health, Population and Hospital Reform (MSPRH) is the regulatory authority responsible for drugs, biologicals, and medical devices for human use in Algeria. The General Directorate of Pharmacy and Health Equipment (DGPES) at MSPRH is the body responsible for reviewing, assessing, regulating, and monitoring pharmaceutical products, since the MSPRH’s new organizational chart implementation in 2012. The National Agency for Pharmaceutical Products (ANPP) was created on July 2, 2018, as a financially independent institution to regulate medicines and other medical products and will gradually replace DGPES upon its establishment. However, ANPP will remain under the administrative authority of the Ministry of Health.

New drugs, biologicals and medical devices cannot be marketed unless MSPRH has authorized them. Applications for market authorization must be submitted to the MSPRH on a form specially prepared for that purpose: generic products, new drug products, medical devices, accompanied by a submission dossier. The authorization process generally involves:
1.     Preliminary examination (at the end of which, an application receipt is granted),
2.     Evaluation of application (including laboratory quality control tests),
3.     Approval or denial of application (on quality/safety/efficacy criteria + price negotiation),
4.     Granting of the market authorization + list price attestation.

Algeria shares information with its citizens and other parties with interest in their health and regulatory system through the MSPRH website. The website contains information about the responsibilities of the MSPRH. The minister delegate to the pharmaceutical industry in the country. Other partner institutions that offer health services to the country are the National Blood Agency, National Registry and National Center for Toxicology, among others. Algeria is part of the CEN-SAD (Community of Sahel–Saharan States) regional community and will benefit from the region’s medicine registration harmonization once created. Currently, the region does not have any medicine regulation harmonization program.