SAHPRA and USP to increase access to 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) works with the United States Pharmacopoeia (USP) to support SAHPRA’s three pillars of safety, quality and efficacy, to ensure that medicines, medical devices and IVDs meet the standards required to protect health and well-being. be of all who reside in South Africa.

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

To this end, SAHPRA and USP will collaborate to:

  • Build capacity to adopt risk-based approaches for regulatory inspections and post-market surveillance
  • Strengthen quality control laboratories for drugs, biologicals and vaccines, as well as medical devices
  • Collaborate in the advancement of regional regulatory harmonization initiatives of strategic importance to SAHPRA and USP
  • Contribute to improving public health in Africa by promoting rapid 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 Chairman and Chief Executive Officer (CEO). “At a time when COVID-19 has wreaked havoc on lives and economies, it is almost mandatory that partnerships of this nature strengthen our initiatives and help us achieve our long-term goals and vision.”

“SAHPRA has been a pillar of regulatory leadership on the African continent,” commented Dr. Ronald T Piervincenzi, CEO of USP. “USP is proud to build on our longstanding programs 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 significant steps towards health security and supply chain resilience.


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