A review of the alignment of the regulatory landscape and the implications of South Africa's delayed ratification of the African medicines agency’s treaty.

Abstract

Introduction: The coronavirus disease 2019 (COVID-19) pandemic caused a surge in national, regional, and political interest in pharmaceutical regulation and production within Africa. African bodies noted beneficial economical and health gains which could be achieved through collaborative regulatory controls throughout Africa. Multiple factors have endangered the safety, quality, and efficacy of pharmaceuticals in Africa and thus the wellbeing of African citizens. Factors include an increased trade of falsified medicines (medical products which misrepresent their purpose or have unknown sources), substandard medicines (medical products which are of poor-quality standards due to poor manufacturing or inadequate quality controls), minimal pharmaceutical production, and poor regulatory controls. To ensure provision of safe medicines and devices to persons within Africa, the African Union (AU) established the African Medicines Agency (AMA) treaty on the 19th of February 2019. The AMA treaty aims to improve access to safe, high-quality and efficacious medicine in Africa. As of September 2025, only 54.5% (30/55) of countries across Africa have signed and formally ratified the treaty, 14.5% (8/55) have signed, thus recognising an intention, but have not yet formally ratified the treaty and 30.1% (17/55) have not ratified nor signed the treaty. South Africa, a major role-player in Africa, is one of seventeen African nations who have not yet signed (recognised) nor formally ratified the agreement.