Algeria Pharmaceutical Industry
Positive regulatory changes in Algeria’s pharmaceutical industry support American companies interested in the country’s pharmaceutical sector.
After years of restricted market access and uncertainty for American pharmaceutical companies, 2021 is finally a year of positive change. Last year, the Algerian Government established the Ministry of Pharmaceutical Industry (MOPI) and the National Agency for Pharmaceutical Products (ANPP) to help modernize Algeria’s pharmaceutical industry. Since their inception, both organizations have made significant progress in several critical areas identified by industry, including drug pricing procedures, overly burdensome regulations, and a dysfunctional process for establishing and maintaining marketing operations.
American pharmaceutical exporters should take note of the following market developments when considering entering or expanding in Algeria:
In December 2020, MOPI issued new regulations to decrease the wait times for registering new drugs dramatically. What used to take up to five years could now take as little as five months for proprietary drugs (four months for technical analysis and one month for pricing) and as little as three months for generic medicines.
At the end of February 2021, MOPI issued regulations that resolved the longstanding issue of representative offices for foreign pharmaceutical companies operating in Algeria. The new regulation permits foreign pharmaceutical companies to market their products locally and establishes clear rules for establishing local pharmaceutical entities. MOPI also allowed for temporary authorizations of up to one year for medicines prescribed to treat serious diseases when there is no equal treatment in the market and when approved by another regulatory body (such as the U.S. Food and Drug Administration).
These positive changes demonstrate MOPI’s desire to improve Algeria’s pharmaceutical industry, and the Commercial Service in Algeria will monitor how these changes impact U.S pharmaceutical companies during the rest of 2021.
For a market briefing on the opportunities and challenges in Algeria’s pharmaceutical market, please contact Jugurtha Rabia firstname.lastname@example.org, Commercial Specialist, U.S. Commercial Service Algeria.