The Medicines Control Authority of Zimbabwe (MCAZ) has approved Lenacapavir, a long-acting HIV prevention medicine, in just 23 days one of the fastest regulatory turnarounds for a major public health product in the country.
In a media release statement, MCAZ said the application by manufacturer Gilead was submitted on 29 October and went through a rigorous expedited review because the product is considered “of major public health importance both in Zimbabwe and globally.”
MCAZ Director-General, Richard Rukwata, said the approval demonstrated the Authority’s commitment to timely access to vital health innovations.
“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products.
This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health,”he said
He said the Authority conducted a comprehensive assessment of the medicine’s safety, efficacy and quality, relying on scientific evaluations from the World Health Organization Prequalification programme to ensure an efficient but robust review.
“We applied a regulatory reliance approach to support a thorough yet streamlined process, without compromising standards,” Rukwata said.
The registration of Lenacapavir is expected to strengthen Zimbabwe’s HIV prevention strategy by offering an alternative to daily oral PrEP and potentially improving adherence among populations most vulnerable to infection.
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MCAZ said it remains committed to ensuring that Zimbabweans have access to “high-quality, safe and effective medical products” that support the country’s fight against HIV/AIDS.
