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...