WHO prequalification of medicines at 25: Celebrating a unique achievement in a changing landscape

We are aware of the British Journal of Clinical Pharmacology's long-standing interest in the use of and access to medicines in low- and middle-income countries (LMICs) and would like to highlight an important programme that revolutionized the way medicines reach people in these countries. In 2001, the World Health Organization (WHO) issued an invitation to pharmaceutical companies to express interest in submitting their products for rigorous regulatory assessment of their quality, safety and efficacy, called prequalification in procurement terms, for HIV/AIDS-related treatments. This was the first step in what became a highly consequential initiative to improve access to quality-assured medicines in LMICs. This programme pioneered the approval of triple fixed-dose combinations—an early breakthrough in HIV/AIDS treatment. In the following years, prequalification transformed how crucial medicines were made accessible, going far beyond HIV/AIDS treatments. At a time when LMICs faced shortages of high-quality medicines, prequalification reshaped procurement and influenced the way national regulators approved medicines: a listing as a prequalified medicine puts products on a fast track to authorisation in many countries relying on WHO's assessments.1, 2 With the recent withdrawal of the United States from the WHO—amid broader scepticism towards global cooperation—it is important to highlight the immense public health benefits of this programme. Within its first 15 years, about 6·5 million patients received HIV treatments with a WHO prequalified medicine.3 In the past 25 years, over 1060 medicines have been prequalified.4 In 2024 alone, the Global Fund helped 25.6 million people to receive HIV treatments, 7.4 million to receive treatment for tuberculosis and 18 million women to receive preventive malaria therapy, while facilitating the treatment of 170 million malaria cases, using quality-assured products including products prequalified by WHO.5, 6 For malaria and first-line tuberculosis treatments, prequalification has facilitated access to around 90% of the products by market value.7 In 2019, an external evaluation estimated that every US dollar invested in running the WHO prequalification programme contributes to savings of approximately 30–40 US dollars.7 Success has stemmed from a unique form of collaboration. Six times a year, regulatory experts meet for prequalification sessions to evaluate medicines. They come from national authorities, including from countries where prequalified medicines are used, and bring both scientific expertise and knowledge of the regulatory environment back home. Furthermore, the assessment reports generated at these sessions have supported more than 1350 national registrations. The 150th session was held in March 2026.4 For many years, the sessions were held at UN City in Copenhagen under the leadership of the recently retired Dr Matthias Stahl, noted for his commitment to the highest standards. During and between sessions, experts assess the quality, efficacy and safety of medicines. They also prepare and update WHO public assessment reports (WHOPARs), which include the WHO-recommended product information aligned with the latest WHO treatment guidelines. WHOPARs are an integral part of prequalification. ‘A medicine is a tablet plus information,’ as one of Dr Stahl's favourite adages goes. The better the information provided to healthcare providers and patients, the better the outcomes one can expect. The sessions stand out for yet another reason: the exchange of knowledge within the international team of assessors. While the impact of the knowledge transfer is difficult to quantify, these sessions have led to a greater understanding of regulatory practices across the world.4, 8 Several assessors have gone on to pursue work on the quality of medicines in organizations, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the WHO itself and other United Nations organizations. In Africa, these assessors have taken leading roles in supporting regional initiatives and the establishment of the African Medicines Agency. As the WHO marks 25 years of the prequalification of medicines, it must recognize the changes to the global health landscape. Regulatory systems are evolving; the African Medicines Agency is set to play a significant role in medicines regulation, and funding pressures following the US withdrawal from the WHO are affecting WHO programmes. Recent funding cuts, partly due to the US withdrawal, have led to the return of COVID-19-era virtual sessions. Although virtual sessions during the pandemic had little impact on the number of products prequalified, permanent virtual sessions could negatively affect output.9 The pioneers of prequalification who first invited pharmaceutical companies to come forward with crucial medicines for HIV, tuberculosis and malaria are heartened by the successes of the programme. Recently, preventive modalities, such as HIV pre-exposure prophylaxis, have become an integral part of prequalification, showcasing the progress from a reactive to a proactive approach to combatting health threats. As the prequalification programme adapts to the new landscape, it is necessary to build on its successes, both tangible and intangible. Continued funding is essential but strengthening hands-on collaboration between medicine regulators will also be needed to preserve the hard-won progress in global health. Regine Lehnert and Nacho Mbaeliachi: Writing–editing. Lembit Rägo: Review–editing. RL and NM declare that they are part-time consultants to the WHO Prequalification of Medicines Programme. LR declares that he worked for the World Health Organization from 1999 to 2016 as Head of Regulation of Medicines/Health Technologies, where he laid the foundations for the WHO Prequalification of Medicines Programme. No aspect of this work was funded by WHO. Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.