From Innovation to Access: WHO’s Plan to Deliver Child-Safe Medicines by 2030

In a groundbreaking initiative spearheaded by the World Health Organization (WHO), alongside global health research leaders like Unitaid, Medicines Patent Pool (MPP), Drugs for Neglected Diseases initiative (DNDi), St. Jude Children’s Research Hospital, the International Union Against Tuberculosis and Lung Disease, and Medicines for Malaria Venture, the world is being called to reimagine how medicines are developed, regulated, and delivered for children. The research outlines a bold five-year plan to address a longstanding, systemic failure: the global health system continues to overlook children when it comes to pharmaceutical innovation and access. Despite historic medical advancements, only 30% of essential medicines exist in child-appropriate formulations, and paediatric versions often lag behind adult treatments by a decade or more. Clinical trials rarely include children, and fragmented systems force healthcare providers to crush or divide adult tablets, an improvised, often unsafe practice. GAP-f, the Global Accelerator for Paediatric Formulations, was created to confront these failures with a systemic, unified response.

From HIV Treatment Breakthrough to Global Framework

The GAP-f model gained credibility following the successful development and global introduction of paediatric dolutegravir (pDTG), an HIV medication previously inaccessible to young children. Historically, bringing such a formulation to market would have taken over 20 years. However, a coordinated network of funders, researchers, industry stakeholders, and regulators fast-tracked the process by more than a decade, delivering life-saving treatment sooner, preventing over 10,000 deaths, and saving an estimated US$ 1.3 billion. This dramatic achievement proved that collaborative acceleration across the drug development lifecycle, from trial design to regulatory approval and country-level rollout, was not only possible but necessary. This proof-of-concept catalyzed GAP-f’s broader mission to apply the same coordinated approach across a wider range of therapeutic areas, including tuberculosis, hepatitis C, childhood cancers, antimicrobial resistance, neglected tropical diseases, and noncommunicable diseases like epilepsy and sickle cell disease.

30 by ’30: A Blueprint for Global Impact

At the heart of the 2025–2030 strategy lies the ambitious “30 by ’30” goal: to accelerate 10 paediatric medicines across 10 therapeutic areas in 10 countries by 2030. The plan is built on two operational axes: alignment and coordination, and enablement through collaboration. These axes are applied throughout the product lifecycle, portfolio prioritization, clinical research, product development and regulation, and access and delivery. GAP-f’s prioritization efforts are data-driven and continuously refined using pipeline analyses, the WHO Expression of Interest lists, and a global product dashboard to ensure transparency and accountability. For clinical research, GAP-f focuses on improving trial design, strengthening research capacity, engaging civil society, and enabling real-world data collection. On the regulatory front, the Paediatric Technology Hub will guide innovation, while new international harmonization guidelines will support unified regulatory pathways. Importantly, the initiative is committed to sustainable, climate-resilient solutions, advocating for heat-stable, eco-friendly formulations that are suitable for low-resource settings.

Country-Led Action, Community-Driven Change

The new roadmap is deeply rooted in ecosystem thinking, recognizing that successful paediatric treatment requires not just new drugs but also diagnostics, policies, health system infrastructure, and community support. GAP-f emphasizes stronger engagement with countries, encouraging national ownership of paediatric health priorities and integration of child-friendly formulations into public health systems. In Southeast Asia, for example, a new initiative funded by the Temasek Foundation aims to build a stronger paediatric medicines ecosystem in Indonesia, Malaysia, the Philippines, and Thailand. By working closely with healthcare professionals and civil society, GAP-f hopes to ensure that new treatments are not only technically sound but also culturally accepted and appropriately used. This inclusive approach will also ensure caregivers’ voices shape drug design and rollout strategies, particularly for diseases like malaria and dengue that disproportionately affect children under five.

Investing in Equity, Efficiency, and Innovation

The strategy estimates a US$ 40 million investment over five years, with 80% dedicated to collaborative activities such as innovative clinical trials and new formulation development. The remaining US$ 8 million will support governance, alignment, and coordination. Guided by three core implementation principles- transparency, mutual accountability, and agility, GAP-f aims to amplify the impact of each donor dollar by eliminating duplication, aligning resources, and accelerating product timelines. Success will be measured not just in medicines developed but in lives saved, disease burdens reduced, and sustainable systems strengthened. The roadmap also lays out a “Theory of Change” that provides clear indicators for progress, including faster clinical development, earlier product approvals, and greater adoption at the national level.