{"id":20687,"date":"2025-07-21T09:23:13","date_gmt":"2025-07-21T08:23:13","guid":{"rendered":"https:\/\/anpp.dz\/a-propos-direction-denregistrement\/"},"modified":"2026-03-13T16:00:30","modified_gmt":"2026-03-13T15:00:30","slug":"a-propos-direction-denregistrement","status":"publish","type":"page","link":"https:\/\/anpp.dz\/en\/a-propos-direction-denregistrement\/","title":{"rendered":"About \u2013 Directorate of Pharmaceutical Products Registration"},"content":{"rendered":"\n

Directorate of Pharmaceutical Product Registration<\/h2>\n\n\n\n

Within the framework of the national public health policy, the registration of pharmaceutical products in Algeria constitutes a crucial step to ensure the safety, quality, and efficacy of medicines made available to the population.<\/p>\n\n\n\n

The Directorate of Pharmaceutical Product Registration<\/strong>, under the supervision of the National Agency for Pharmaceutical Products (ANPP)<\/strong>, is responsible for the registration of pharmaceutical products and for issuing the registration decision and its renewal. When applicable, it also handles the suspension, withdrawal, transfer, or assignment of registrations, following the recommendation of the Pharmaceutical Product Registration Committee, in accordance with Executive Decree No. 19-190 of 30 Shawwal 1440, corresponding to July 3, 2019, which defines the missions, organization, and functioning of the National Agency for Pharmaceutical Products.<\/p>\n\n\n\n

Missions<\/h2>\n\n\n\n

The Directorate of Pharmaceutical Product Registration is responsible for:<\/p>\n\n\n\n

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Registering pharmaceutical products for human use, issuing the registration decision, and renewing and\/or modifying it, and, where applicable, withdrawing it.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Issuing the price certificate for medicines submitted for registration, once it is set by the Intersectoral Economic Committee for Medicines.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Conducting the evaluation of scientific documentation on the benefits, risks, and therapeutic value of pharmaceutical products, as well as their health-economic assessment.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n<\/div>\n\n\n\n

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Issuing opinions on temporary use authorizations (ATU) for unregistered medicines.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Contributing to the development strategies of pharmaceutical products.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Developing and implementing the registration strategy for pharmaceutical products.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n<\/div>\n\n\n\n

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Contributing to the establishment and updating of the national pharmaceutical product nomenclature.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Assisting in the development of the essential medicines list.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Participating in the preparation of the list of reimbursable medicines by social security organizations.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n<\/div>\n\n\n\n

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Making proposals within the framework of drafting regulatory texts related to pharmaceutical products.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Providing secretariat services for the Pharmaceutical Product Registration Committee and the Intersectoral Economic Committee for Medicines.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n\n\n\n

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Evaluating actions undertaken in pharmaceutical product registration and preparing performance reports.<\/summary>\n

<\/p>\n<\/details>\n<\/div>\n<\/div>\n\n\n\n

The Directorate of Pharmaceutical Product Registration relies, in processing and granting registration decisions, on several specialized bodies defined by Algerian regulations.<\/p>\n\n\n\n

It notably collaborates with:<\/p>\n\n\n\n

    \n
  • The National Pharmaceutical Product Registration Commission<\/strong>, an advisory body responsible for providing opinions on registration, renewal, and modification requests, in accordance with Executive Decree No. 21-82 of February 17, 2021.<\/strong><\/li>\n\n\n\n
  • The Scientific Expert Committee,<\/strong> composed of specialists in pharmacy, medicine, toxicology, and related fields, which provides opinions on the therapeutic relevance of submitted files .<\/li>\n\n\n\n
  • The Economic Committee for Pharmaceutical Products,<\/strong> responsible for evaluating economic aspects related to products (price, cost-effectiveness), in accordance with regulations on medicine pricing and control.<\/li>\n<\/ul>\n\n\n\n

    This structure ensures a rigorous, objective, and multidisciplinary evaluation, while guaranteeing transparency and compliance of the registration process with national public health requirements.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Directorate of Pharmaceutical Product Registration Within the framework of the national public health policy, the registration of pharmaceutical products in Algeria constitutes a crucial step to ensure the safety, quality, and efficacy of medicines made available to the population. The Directorate of Pharmaceutical Product Registration, under the supervision of the National Agency for Pharmaceutical Products […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-20687","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/20687","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/comments?post=20687"}],"version-history":[{"count":5,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/20687\/revisions"}],"predecessor-version":[{"id":22036,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/20687\/revisions\/22036"}],"wp:attachment":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/media?parent=20687"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}