Pediatric Regulatory Initiatives

  • Steven Hirschfeld
  • Agnes Saint-Raymond
Part of the Handbook of Experimental Pharmacology book series (HEP, volume 205)


A series of government actions have evolved since the 1990s to facilitate the development of medicinal products for pediatric use using a combination of incentives and mandates. The initiatives have been successful in stimulating activity and interest in products developed for pediatric use. The initiatives continue to evolve as experience accumulates and regulatory agencies develop robust cooperative programs. A multidimensional program is necessary to achieve the necessary goal of aligning pediatric therapeutics with adult therapeutics and providing children the most favorable opportunity to benefit and minimize risk to vulnerable populations.


Pediatric medicines Therapeutic orphans ICH E11 guidelines United States Federal Pediatric Initiatives European Pediatric Regulation Written request Pediatric rules Pediatric investigation plan Waivers Deferrals 


  1. Decisions on PIP or Waivers. Accessed 11 Jan 2010
  2. European Medicines Agency pediatric webpage Accessed 11 Jan 2010
  3. Network of pediatric research. Accessed 11 Jan 2010
  4. Paediatric Committee Accessed 11 Jan 2010
  5. 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 (as amended). Accessed 11 Jan 2010

Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  1. 1.National Children’s Study Eunice Kennedy Shriver, National Institute of Child Health and Human DevelopmentBethesdaUSA
  2. 2.Scientific Advice, Paediatrics, and Orphan Drug SectorEuropean Medicines AgencyLondonUK

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