South Africa’s medicines’ regulatory submission process is well governed, and there are numerous guidelines available, many following EU standards. The pharmaceutical regulating body in South Africa, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals (See Table 1 for MCC contact information). In ...

Northern Africa is an emerging region that presents a unique and diverse set of regulatory considerations . Through the World Health Organization (WHO), US Food and Drug Administration (FDA) and European Medicines Agency (EMA), sponsors have been able to leverage the regulatory review and approval of medicines in International Conference on Harmonization (ICH) countries to access drugs to treat major diseases. While some of these regulatory pathways, including the...

The African Medicines Regulatory Harmonization (AMRH) initiative mandate included the establishment of regional centers of regulatory excellence (RCOREs) in several fields. The goal was to strengthen regulatory capacity development by providing academic and technical training in regulatory science. RCOREs’ mission is training a regulatory workforce in Africa through the following routes: 1 providing academic and technical training in regulatory science applicab...

African countries represent an increasingly important target for vaccines and medicines to treat or prevent endemic infectious diseases (e.g., tuberculosis (TB) and malaria). A large portion of Central Africa still experiences unmet medical needs from bacterial and tropical diseases. This situation is due to a lack of new drugs that can stay ahead of the challenge of drug resistance, the high cost of modern medicines and the scarcity of access to healthcare programs...

Determining a regulatory strategy for a specific West African country requires assessment of infrastructure, resources and sponsor-agency relationships to achieve the best results. Sponsors must consider several regulatory hurdles when defining West African regulatory marketing application requirements, often without established guidelines. A myriad of government, non-government and regulatory organizations provide support to the region, and understanding their interactio...

When developing a regional African regulatory strategy, it is very important to make an early determination of the key markets that will be targeted based on the size of country vs. medical need, time to approval, competition, language, etc. This article addresses East and Southern Africa, as they are major markets that often follow European initiatives and, for the most part, are English speaking. Target countries within these markets might be those where sponsors can ob...