Dr Beatrice Matanje, executive director of the National AIDS Commission, said the decision marked a significant milestone in the country’s HIV response. She told media that a twice-yearly injection would ease the burden of adherence and clinic visits, potentially reshaping prevention outcomes. PMRA Director General Mphatso Kawaye called the approval a deliberate effort to speed up access to life-saving medical innovations, saying it demonstrated the authority’s commitment to fast-tracking safe and effective treatments.
The approval process was supported by the European Medicines Agency and the World Health Organization, both of which have been helping accelerate regulatory decisions across Southern Africa. South Africa, Zambia and Zimbabwe have already authorised the drug. The Global Fund has pledged support for Malawi’s rollout, with the first consignments expected to reach Africa before the end of the year, according to a recent statement from the organisation. Malawi continues to face one of the world’s highest HIV prevalence rates. The National AIDS Commission estimates that about 950,000 people, the majority women and children, are living with HIV.