SAHPRA - Relevance of the New South African Health Products Regulatory Authority and Opportunities Ahead

Abstract

Regulatory environments are constantly evolving, and South Africa has witnessed some significant developments in the recent past. Operational launch of the South African Health Products Regulatory Authority (SAHPRA) as new healthcare products regulator marks a key milestone in the establishment of international standards in regulatory practices. Both the Medicines Control Council (MCC) and the Directorate of Radiation Control (DRC) were replaced by SAHPRA to bring control of medicines, medical devices, in vitro diagnostic tests and devices, and radiation emitting products under one regulatory body. The new agency was instituted under schedule 3A of Public Finance Management Act as public entity, thereby enabling it to retain the revenue generated. The change has evidently impacted the regulatory practices positively; however, the challenges inherited by regulators and those regulated are enormous. SAHPRA needs to confront the challenges and make the most out of the opportunities ahead. This study aims to focus on understanding the new agency, its evolution over time, objectives set forth, organizational and operational construct, responsibilities, accomplishments so far, outstanding challenges, opportunities ahead, and the collaborative efforts that can support its operation. SAHPRA has had noteworthy achievements as a healthcare products regulator. By making most use of collaboration efforts SAHPRA is all set to work through the challenges and gain from opportunities. https://doi.org/10.21423/jrs-v09i2dureja