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Pharmaceutical Registration in Algeria

Streamlined Pharmaceutical Registration in Algeria: Accelerated Process for 2021 and Beyond

Algeria MoH link

https://ghdx.healthdata.org/organizations/ministry-health-and-population-algeria

Algeria Market Value: Algeria, the second-largest pharmaceutical market in Africa after South Africa, has witnessed robust growth over the past decade, with a remarkable 17% increase, reaching an estimated value of US $4 billion, as reported by the Algerian Minister of Pharmaceutical Industry. The pharmaceutical import bill in 2019 amounted to US $2 billion, encompassing significant allocations of $600 million for cancer medications and $400 million for insulin to manage diabetes. Notably, Canadian pharmaceutical exports to Algeria surged from $4.4 million in 2016 to $24 million in 2018, indicating a substantial expansion, according to Algerian customs data. Major international pharmaceutical players, particularly from France, dominate the Algerian market, with companies like Sanofi, Novo Nordisk, Pfizer, El Kendi, Hikma, gsK, and local entities such as groupe Saidal, Merinal Laboratories, and Biopharm. In response to the sector’s growing importance, Algeria underwent a cabinet reshuffle in June 2020, establishing a dedicated Ministry of Pharmaceutical Industry. This move signals a commitment to enhance the industry by overseeing regulatory aspects, ensuring drug accessibility, managing imports, and implementing price controls. The newly established National Drug Agency is set to be reinforced to simplify the registration process. Aligned with a broader governmental strategy, Algeria aims to bolster local pharmaceutical production and reduce reliance on imports. The target is to achieve a remarkable 70% of local manufacturing, particularly in generics, by 2022. To encourage this shift, the government has implemented a ban on certain imported drugs that are locally manufactured and introduced tax incentives. Local drug production has surged, constituting 52% of the market share, totaling around US $2 billion in 2018. The pharmaceutical sector holds a strategic status in Algeria, as evidenced by its inclusion in the complementary finance bill for 2020 (LFC 2020). The 51/49 rule, limiting foreign investor participation to 49%, applies to pharmaceutical industries. However, exemptions are granted for investments related to the production of innovative, high-value essential products utilizing complex and protected technology, both for the domestic market and export.

Registration process in Algeria: The pharmaceutical registration process in Algeria follows a structured two-step procedure initiated in 1996. In the initial step, pharmaceutical companies submit an application using the prescribed Fiche de Soumission de Produits Pharmaceutiques an l’Enregistrement format. This application requires comprehensive information, including the drug’s international name, form, dosage, factory prices with taxes, and fob/cif, along with the proposed price in the Algerian market. Additionally, details on how the medication will contribute to improving the health situation in Algeria, the market price in the country of origin, and prices in three other nations are essential. The Health Ministry reviews the application to determine the necessity of the medicinal product in the country and decides whether to accept detailed dossiers for its registration. Ideally, the medicine seeking registration should be listed in the Nomenclature Nationale des Medicaments. However, if not listed, an additional application using the Formulaire d ‘Information Therapeutique en vue de l”enregistrement en Algerie is required. This form seeks more detailed information on the characteristics, administration mode, pharmacological properties, efficiency, and therapeutic risks of the medicine. Upon acceptance of the initial submission, the pharmaceutical company proceeds to the second step, where a detailed dossier is submitted according to the Procedures d’expertises analytiques pharmacotoxicologie et cliniques appliques aux produits pharmaceutiques. This dossier, sent in triplicate, includes original and copy documents, along with two samples for each dosage form under consideration. Technical information on the product, quantity, lot manufacturer, and expiry dates, provided through the Echantillons Medicaux Gratuits form, aids in customs clearance in Algiers. One set of samples is directed to the Laboratoire Nationale de Controle des Produits Pharmaceutiques, typically requiring 30 ampoule units for drugs of 5 ml/mg or above and 50 ampoule units for drugs of 1 to 1.5 ml.

In 2021, a notable shift in the Algerian pharmaceutical landscape emerged, marking a positive turn for American pharmaceutical companies after years of constrained market access and uncertainty. The Algerian Government responded to industry needs by establishing the Ministry of Pharmaceutical Industry (MOPI) and the National Agency for Pharmaceutical Products (ANPP). These entities swiftly progressed in vital areas, addressing concerns such as convoluted drug pricing procedures, burdensome regulations, and dysfunctional processes for establishing and sustaining marketing operations.

 

Key developments beckon the attention of American pharmaceutical exporters eyeing Algeria’s market: In December 2020, MOPI enacted regulations significantly slashing the time required for registering new drugs, reducing the timeline from up to five years to as little as five months for proprietary drugs and three months for generic medicines. By the end of February 2021, MOPI resolved a longstanding issue concerning representative offices for foreign pharmaceutical companies in Algeria. The new regulations permit foreign companies to locally market their products, establishing transparent rules for creating local pharmaceutical entities. Additionally, MOPI introduced temporary authorizations for up to one year for medicines treating serious diseases without equivalent market alternatives, subject to approval by regulatory bodies like the U.S. Food and Drug Administration. These transformative measures underscore MOPI’s commitment to enhancing Algeria’s pharmaceutical sector, and the U.S. Commercial Service in Algeria remains vigilant in monitoring their impact on American pharmaceutical companies throughout 2021.