The availability of licensed paediatric drugs is lagging behind those for adults,\nand there is a lack of safe formulations in suitable doses that children are able and willing to\ntake. As a consequence, children are commonly treated with off-label or unlicensed drugs. As\noff-label and unlicensed drug use are associated with a greater risk for harm than on-label\ndrug use, a range of global initiatives have been developed to realize Bbetter^ medicines for\nchildren. This review describes the challenges and achievements of the European Union to\nrealize this goal, with a focus on paediatric drug development and formulation design. In\n2007, a European Paediatric Regulation was installed enforcing companies to consider\nchildren in the early development of drugs with a new drug substance, for a new indication or\nwith a new route of administration. The Regulation, e.g. requires companies to develop a\npaediatric investigation plan discussing the proposed clinical trials in children of different\nages and the formulations for future marketing. Since 2013, the pharmaceutical design of any\nnewly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical\nDevelopment of Medicines for Paediatric Use.^ Companies should, e.g. justify the route of\nadministration, dosage form, formulation characteristics, safety of excipients, dosing\nfrequency, container closure system, administration device, patient acceptability and user\ninformation. In this review, the guideline�s key aspects are discussed with a focus on novel\nformulations such as mini-tablets and orodispersible films, excipients with a potential risk for\nharm such as azo dyes and adequate user instructions.
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