1. Regulation (EC) No. 1901/2006, of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf. Accessed 4 May 2018.
2. Report from the Commission to the European Parliament and the Council. State of Paediatric Medicines in the EU. 10 years of the EU Paediatric Regulation. COM (2017) 626. https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf. Accessed 8 May 2018.
3. FDA Fact Sheet: Pediatric provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm311038.htm. Accessed 7 May 2018.
4. EMA/PDCO Policy on the determination of the condition(s) for a Paediatric Investigation Plan/Waiver. 30 July 2012 EMA/272931/2011 Human Medicines Development and Evaluation. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/09/WC500133065.pdf. Accessed 8 May 2018.
5. Guidance for industry. Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry;Draft,2016