Introduction: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007\nPaediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric\nInvestigation Plans (PIPs) are subject to agreement by the European Medicines Agency (EMA) and its Paediatric Committee\n(PDCO). The aim of this study was to evaluate the key characteristics of oral paediatric medicines in the PIPs and the\nchanges implemented as a result of the EMA/PDCO review.\nMethods: All PIPs agreed by 31 December 2011 were identified through a proprietary EMA-database. PIPs were included if\nthey contained an agreed proposal to develop an oral medicine for children 0 to 11 years. Information on the therapeutic\narea (EMA classification system); target age range (as defined by industry) and pharmaceutical characteristics (active\nsubstance, dosage form(s) as listed in the PIP, strength of each dosage form, excipients in each strength of each dosage\nform) was extracted from the EMA website or the EMA/PDCO assessment reports.\nResults: A hundred and fifty PIPs were included corresponding to 16 therapeutic areas and 220 oral dosage forms in 431\nstrengths/compositions. Eighty-two PIPs (37%) included tablets, 44 (20%) liquids and 35 (16%) dosage forms with a specific\ncomposition/strength that were stored as a solid but swallowed as a liquid e.g. dispersible tablets. The EMA/PDCO review\nresulted in an increase of 13 (207 to 220) oral paediatric dosage forms and 44 (387 to 431) dosage forms with a specific\ncomposition/strength. For many PIPs, the target age range was widened and the excipient composition and usability\naspects modified.\nConclusion: The EMA/PDCO review realized an increase in the number of requirements for the development of oral dosage\nforms and a larger increase in the number of dosage forms with a specific composition/strength, both targeting younger\nchildren. Changes to their pharmaceutical design were less profound.
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