Agence Nationale des Produits Pharmaceutiques (ANPP), Algeria

The Agence Nationale des Produits Pharmaceutiques was created by article 223 of Law No. 18-11 of 2 July 2018 on health, as a public body with legal personality and financial autonomy under the Ministry of Health; ordinance No. 20-02 of 30 August 2020 moved it under the Ministry of Pharmaceutical Industry. Executive decree No. 19-190 of 3 July 2019 sets its missions and organisation. Its directorate for the registration of pharmaceutical products registers medicines for human use and grants, renews, suspends or withdraws registration after the opinion of the registration commission; issues the price certificate after the interministerial economic committee for medicines has fixed the price; assesses benefit, risk, therapeutic value and medico-economic evaluation; gives opinions on temporary authorisations for unregistered medicines; and takes part in drawing up the list of medicines covered by social security. Its offices are at Cité Djiroud, Staouéli, Dely Ibrahim, Algiers; the coordinates are a Dely Ibrahim district point.

Executive decree No. 20-325 of 22 November 2020 requires a pre-submission request before any registration application, a dossier in the Common Technical Document format, and, for an imported product, registration and marketing in its country of origin on the date of the application. The agency must decide within 150 days of finding a dossier admissible, exceptionally extendable by up to 90 days, with the clock stopped while further information is requested; a registration is valid for five years. In 2025 the agency held a self-assessment workshop with the World Health Organization (15 June) towards maturity level 3, which the minister of pharmaceutical industry said would open international markets to medicines made in Algeria, and its director general presented on regulatory reliance at an African ministerial conference on local production of medicines in Algiers (27 to 29 November 2025).