Accelerating optimal approval of priority formulations for antibiotic use in children

Book excerpt: On 24 March 2023, WHO launched the first-ever list of priority paediatric formulations for antibiotics, addressing critical gaps in age-appropriate treatments for infants and children. This list, developed through WHO’s Paediatric Drug Optimization (PADO) process, identifies antibiotics urgently needing development to treat infections from high-priority pathogens. WHO, leveraging GAP-f and partners like GARDP and PENTA, led a technical consultation that concluded in March 2024 to review regulatory frameworks and streamline clinical research, aiming to accelerate regulatory approvals and ensure equitable access to effective treatments. The outcomes of this meeting are captured in this report, underscoring the collaborative efforts needed to advance essential paediatric formulations, minimize delays, and support globally aligned, evidence-based care for serious infections in children.