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The New European Regulation on Pediatric Medicines

Regulatory Perspective

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References

  1. EU regulation (EC) No 1901/2006 of the European Parliament and of the council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and regulation (EC) No 726/2004. 2007

  2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: clinical investigation of medicinal products in the pediatric population. E11. Current step 4 version, 20 July 2000 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA487.pdf [Accessed 2008 Feb 21]

  3. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. Br Med J 2000; 320: 79–82

    Article  CAS  Google Scholar 

  4. US FDA. Food and Drug Administration Modernization Act of 1997 [online]. Available from URL: http://www.fda.gov/cder/guidance/105-115.htm [Accessed 2008 Apr 4]

  5. The European Agency for the Evaluation of Medicinal Products, Human Evaluations Unit. Report on the experts round table on the difficulties related to the use of new medicinal products in children held on 18 December 1997 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/regaffair/2716498en.pdf [Accessed 2008 Feb 21]

  6. The Council of the European Union. Draft Council Resolution on paediatric medicinal products [online]. Available from URL: http://register.consilium.europa.eu/pdf/en/00/st13/13187enO.pdf [Accessed 2008 Apr 4]

  7. The Council of the European Union. Regulatory measures for paediatric medicinal products: Belgian delegation submission [online]. Available from URL: http://register.consilium.europa.eu/pdf/en/03/st09/st09933en03.pdf [Accessed 2008 Apr 4]

  8. Food and Drug Administration. Best Pharmaceuticals for Children Act [online]. Available from URL: http://www.fda.gov/opacom/laws/pharmkids/pharmkids.html [Accessed 2008 Apr 4]

  9. Food and Drug Administration. Pediatric Research Equity Act [online]. Available from URL: http://www.fda.gov/cder/pediatric/S-650-PREA.pdf [Accessed 2008 Apr 4]

  10. European Union. Proposal for a regulation of the European Parliament and of the council on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, Directive 2001/83/EC and regulation (EC) No 726/2004. Available from URL: http://register.consilium.europa.eu/pdf/en/04/st13/st13/st13880.en04.pdf [Accessed 2008 Apr 4]

  11. Dunne J. The European regulation on medicines for paediatric use. Paediatr Respir Rev 2007; 8: 177–83

    Article  PubMed  Google Scholar 

  12. European Economic Community. Council regulation EEC No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. 1992 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_1992_1768/reg_1992_1768_en.pdf [Accessed 2008 Apr 4]

  13. Permanand G, Mossialos E, McKee M. The EU’s new paediatric medicines legislation: serving children’s needs? Arch Dis Child 2007; 92: 808–11

    Article  PubMed  Google Scholar 

  14. European Medicines Agency. Medicines for children: scientific advice [online]. Available from URL: http://www.emea.europa.eu/htms/human/paediatrics/sci_advice.htm [Accessed 2008 Apr 4]

  15. Birenbaum D. Best Pharmaceuticals for Children Act: an FDA implementation perspective [online]. Available from URL: http://www.fda.gov/CDER/pediatric/presentation/dlb-DIA-Mar2003/sld001.htm [Accessed 2008 Apr 4]

  16. Paediatric medicines: proposed EU regulation -report with evidence, European Union Committee Report (20th Report Session 2005–06). London: Stationery Office. UK House of Lords, 2006

  17. Cohen IG. Therapeutic orphans, pediatric victims? The best Pharmaceuticals for children act and existing pediatric human subject protection. Food Drug Law J 2003; 58: 661–710

    PubMed  Google Scholar 

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Acknowledgments

D.B. Hawcutt and R.L. Smyth are members of the National Institute for Health Research (NIHR) Faculty and are partly funded by the NIHR. The authors have no conflicts of interest that are directly relevant to the content of this article.

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Authors and Affiliations

  1. Division of Child Health, School of Reproductive and Developmental Medicine, University of Liverpool, Alder Hey Children’s Hospital, Liverpool, L12 2AP, UK

    Daniel B. Hawcutt &  Rosalind L. Smyth

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  1. Daniel B. Hawcutt
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  2. Rosalind L. Smyth
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Correspondence to Rosalind L. Smyth.

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Hawcutt, D.B., Smyth, R.L. The New European Regulation on Pediatric Medicines. Pediatr-Drugs 10, 143–146 (2008). https://doi.org/10.2165/00148581-200810030-00002

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