SAHPRA and USP Announce MOU to Advance Regulatory Oversight for Medical Products in South Africa

14 January 2022

Embargo: Immediate release

Joint Media Statement

The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MOU) with the U.S. Pharmacopeia (USP) to help expand the availability of health products, including medical devices, that are safe, efficacious, and of assured quality.

SAHPRA, the health products regulator in South Africa, is collaborating with USP, an independent, scientific non-profit organisation, to support SAHPRA’s three pillars of safety, quality, and efficacy and its overall aim to achieve the World Health Organisation 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. 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,” indicates SAHPRA Chief Executive Officer (CEO), Dr Boitumelo Semete-Makokotlela.

“SAHPRA has been a mainstay of regulatory leadership on the African continent,” says Ronald T. Piervincenzi, Ph.D., USP CEO. “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 important steps

toward health security and supply chain resiliency.”

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