On World Children’s Day, the Global Accelerator for Paediatric Formulations Network (GAP-f) has intensified its advocacy for improved access to essential and age-appropriate medicines for children. Millions of children, particularly in low-resource settings, continue to encounter significant barriers in obtaining necessary medications. These challenges stem from persistent gaps in research, policy frameworks, and timely investments in paediatric healthcare.
Earlier this year, at the 77th World Health Assembly (WHA), GAP-f unveiled its Strategic Roadmap 2025–2030. This comprehensive strategy aims to bridge the existing gaps in paediatric medicines by focusing on three key shifts that will enhance collaboration among science, policy, and healthcare delivery. The overarching goal is to ensure that no child is left behind in accessing vital treatments.
GAP-f has made notable progress in its mission, particularly through partnerships with the World Health Organization (WHO) and its technical departments. This year, GAP-f successfully completed prioritization exercises targeting several critical health issues affecting children, including respiratory syncytial virus (RSV), malaria, epilepsy, dengue, and sickle cell disease. These areas were chosen based on transparent prioritization principles that guide GAP-f’s focus on diseases impacting children’s health.
The Paediatric Drug Optimization (PADO) process has emerged as a cornerstone of GAP-f’s approach. This evidence-driven initiative defines priority product needs for children, guiding research and development investments while aligning stakeholders around crucial formulations. According to Dévora Kestel, Director a.i. of the Noncommunicable Diseases and Mental Health Department at WHO, the recent PADO-Epilepsy report serves as a vital tool for improving access to child-friendly medications for epilepsy treatment. The report aims to synchronize efforts among funders, developers, regulators, and procurement partners to translate scientific advancements into accessible paediatric antiseizure medicines.
In addition, WHO has introduced six new target product profiles for child-friendly formulations of essential cancer medications. These profiles offer pharmaceutical manufacturers a clear pathway to develop optimized medicines intended specifically for children. Developed through WHO’s standard procedures, including an expert consultation held virtually in December 2024, these target product profiles are expected to facilitate future inclusion in WHO’s Prequalification Expression of Interest list and, ultimately, in the Model List of Essential Medicines for Children.
The recent release of these profiles follows the earlier introduction of two target product profiles for antibiotics, nitrofurantoin and azithromycin, which aim to enhance access to essential antibiotics for treating bacterial infections in children. Over the past four years, under the GAP-f collaboration framework, WHO has conducted a thorough review of formulations included in the Essential Medicines List for Children (EMLc). This review informed both the ninth and the most recent tenth updates of the Model List.
The review assessed perceived needs and formulation gaps among healthcare workers globally while analyzing the current market landscape for child-appropriate medicines. This process led to significant updates to the EMLc, including the addition of 163 new formulations and the removal of 92 outdated formulations. The findings from this comprehensive review underscore the necessity of ensuring that the EMLc remains the most authoritative global reference for national health agencies and procurement entities.
Currently, WHO is focused on monitoring the uptake of the EMLc and assisting countries, initially in the South-East Asia region, to identify national solutions that will strengthen their paediatric medicines ecosystem. This initiative aims to ensure that children have access to age-appropriate formulations.
The GAP-f network, hosted by WHO, includes over 30 partners spanning industry, academia, civil society, and global health institutions. Together, the network is dedicated to eliminating barriers to the development and delivery of appropriate, quality, affordable, and accessible medicines for children worldwide. As World Children’s Day is commemorated, GAP-f emphasizes the importance of collective efforts to achieve better medicines for every child, everywhere.
