SAHPRA and USP to increase availability of safe health products in South Africa

SAHPRA and US Pharmacopeia have signed a Memorandum of Understanding to expand access to quality-assured health products in South Africa.


The South African Health Products Regulatory Authority (SAHPRA) is collaborating with US Pharmacopeia (USP) to support SAHPRA’s three pillars of safety, quality and efficacy, to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of all who reside in South Africa.

The Memorandum of Understanding (MoU) will also see USP aid SAHPRA in its overall aim to achieve the World Health Organization (WHO) Maturity Level 4, designated for regulatory systems that operate at the most advanced levels of performance. These advances will help accelerate and expand access to essential health products and improve oversight of the growing local pharmaceutical and health products manufacturing industry in South Africa.

To this end, SAHPRA and USP will collaborate to:

  • Strengthen capacity for the adoption of risk-based approaches for regulatory inspections and post-marketing surveillance
  • Strengthen quality control laboratories for medicines, biologicals and vaccines, as well as medical devices
  • Collaborate on advancing regional regulatory harmonisation initiatives of strategic importance for SAHPRA and USP
  • Contribute to improving public health in Africa by promoting timely access to quality-assured health products and advancing innovation.

“This MOU will ensure that SAHPRA achieves world-class standards through a firm partnership agreement with USP,” explained Dr Boitumelo Semete-Makokotlela, SAHPRA Chief Executive Officer (CEO). “In an era where COVID-19 has wreaked havoc with lives and economies, it is virtually obligatory that partnerships of this nature will strengthen our initiatives and assist us in achieving our goals and long-term vision.”

“SAHPRA has been a mainstay of regulatory leadership on the African continent,” commented Dr Ronald T Piervincenzi, USP CEO. “USP is proud to build on our longstanding programmes that support quality medicines in the region. Our partnership with SAHPRA will advance regulatory leadership, particularly as South Africa emerges as a regional manufacturing hub and takes important steps toward health security and supply chain resiliency.”