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Paediatric Pharmaceutical Legislation and Its Impact on Adult and Paediatric Drug Development: The EU Regulatory View

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Pediatric Formulations

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 11))

Abstract

The Paediatric Regulation in the European Union sets up a framework governing mandatory requirements and incentives for industry in development of new medicinal products as well as a series of accompanying measures to facilitate approaches to gain access and improve exchange of relevant information on medicinal products in paediatric use. This chapter first presents an overview of this regulatory framework and the requirements that have to be met by industry. It describes the role of the Paediatric Committee (PDCO) at the European Medicines Agency (EMA) and the main points to consider in discussing Paediatric Investigation Plans (PIP). The second part focuses on the specific implications of this regulatory framework on the development of drug formulations for paediatric populations. Essential elements to ensure suitably adapted formulations are reviewed, focusing on dosing appropriateness, acceptability and safety for all relevant age groups.

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References

  1. European Society for Developmental Perinatal & Pediatric Pharmacology. www.esdppp.org. Accessed 17 Dec 2013

  2. The European paediatric initiative: history of the paediatric regulation (2007) (EMEA/17967/04 Rev 1). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/09/WC500003693.pdf

  3. European Medicines Agency (2001) Note for guidance on clinical investigation of medicinal products in the paediatric population (ICH Topic E11) (CPMP/ICH/2711/99). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf

  4. European Medicines Agency (2010) Report on the survey of all paediatric uses of medicinal products in Europe (EMA/794083/2009). http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101006.pdf

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Correspondence to Siri Wang .

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© 2014 American Association of Pharmaceutical Scientists

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Wang, S., Huemer, KH. (2014). Paediatric Pharmaceutical Legislation and Its Impact on Adult and Paediatric Drug Development: The EU Regulatory View. In: Bar-Shalom, D., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 11. Springer, New York, NY. https://doi.org/10.1007/978-1-4899-8011-3_27

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