Challenges for the global research and development of pediatric medicines are technical, ethical and financial. Early collaboration among all stakeholders is required to identify treatments to be developed and how to develop them…A balanced approach to the provision of assured quality pediatric medicines based on scientific and risk/benefit considerations…will provide better access to pediatric medicines which meet the patient’s and the practitioner’s needs…Medicines for children in developing countries should meet the same universal quality standards as for the developed world…Many of the essential medicines for child survival are off-patent and so there may be a role for other stakeholders in addition to R&D companies in the manufacture and supply of those medicines…