Africa CDC Statement On Revital Healthcare EPZ Ltd. Achieving WHO Prequalification for Early-Activation Auto-Disable Syringe

press release

The Africa Centers for Disease Prevention and Control (Africa CDC) proudly commends Revital Healthcare EPZ Ltd for achieving a significant milestone in African manufacturing excellence. This year, Revital Healthcare EPZ Ltd. became the first African company to be granted Pre-Qualification (PQ) status by the World Health Organization (WHO) for their early activation auto-disable (AD) syringe.

While eight manufacturers worldwide have WHO PQ status for this product, Revital Healthcare EPZ Ltd. stands as the first and only African producer. This milestone is expected to revolutionize the healthcare landscape in Africa by reducing average syringe transport times by up to 80-90%, crucial for rapid outbreak responses and timely immunization campaigns. Revital is now poised to produce over 300 million AD syringes annually, strengthening Africa's healthcare infrastructure and securing the supply of essential medical equipment on the continent.

In line with its vision for a New Public Health Order, Africa CDC is committed to strengthening local manufacturing capabilities on the continent. We recognise that achieving WHO PQ status for the company's early activation auto-disable syringe is a significant step towards self-reliance in healthcare product production. This achievement aligns with Africa CDC's goals of promoting local manufacturing excellence to enhance healthcare delivery and ensure the availability of critical medical supplies on the continent, and high-quality regulatory approval of African products is a crucial part of this. The Revital Healthcare approval serves to highlight, why Africa CDC continue to call for focused and supportive regulatory processes, for African manufacturers. We call on WHO, investors and other partners, to strengthen their efforts to and work in support of African manufacturing, including regulatory facilitation and support, and to do so in collaboration and coordination with Africa.

Revital Healthcare EPZ Ltd.'s accomplishment exemplifies the potential of African innovation and manufacturing prowess. It underscores our collective commitment to building a resilient and self-sufficient healthcare ecosystem in Africa. As Africa CDC, we look forward to working closely with Revital Healthcare, to support the necessary pooled pooled procurement and market access.

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