USP and SAHPRA: A Partnership for Health Regulatory Excellence

By Danélia Botes

September 14, 2023

The United States Pharmacopeia (USP) recently welcomed an executive delegation from the South African Health Products Regulatory Authority (SAHPRA) to its Rockville headquarters. This visit marked the culmination of a two-part series, during which both organisations exchanged ideas and explored areas of expanded technical collaboration.

Strengthening the Bond

In 2022, USP and SAHPRA signed a Memorandum of Understanding (MOU) aiming to expand the availability of health products that are safe, effective, and of assured quality. The partnership also seeks to support SAHPRA in achieving the World Health Organization Maturity Level 4, a status that distinguishes regulatory systems operating at the most advanced levels of performance.

The Road Ahead

SAHPRA CEO Dr. Boitumelo Semete-Makokotlela expressed optimism about the partnership. She stated that the collaboration with USP would bolster their ability to respond to today’s regulatory challenges using state-of-the-art science in quality assurance and regulatory practice.

A Commitment to Global Health

In December 2022, the Promoting the Quality of Medicines Plus (PQM+) program, funded by the U.S. Agency for International Development and implemented by USP, organized a joint workshop with SAHPRA. The workshop aimed to strengthen regulatory oversight of vaccines in the region as part of the U.S. Government’s Global VAX initiative.

About the Organizations

SAHPRA’s mandate includes regulating all health products, overseeing radiation control, and ensuring the safety, efficacy, and quality of medicines, medical devices, and in-vitro diagnostics (IVDs). Similarly, the USP is an independent, scientific nonprofit organisation working to strengthen the global supply chain for safe, quality medicines. The PQM+ Program is a cooperative agreement between USAID and USP to sustainably strengthen medical product quality assurance systems in low- and middle-income countries. 

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