1. European Parliament and the Council of the European Union (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Communities L121:34–44
2. European Parliament and the Council of the European Union (2006) Regulation (EC) No 1901/2006, 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. Off J Eur Union L378:1–19
3. European Parliament and the Council of the European Union (2006) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Off J Eur Union L378:20–21
4. European Medicines Agency (2001) ICH/Topic E11. Clinical Investigation of Medicinal Products in the Paediatric Population. Step 5—Note for guidance on clinical investigation of medicinal products in the paediatric population. CPMP/ICH/2711/99. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf . Accessed 24 December 2010
5. Committee for Medicinal Products for Human Use—CHMP (2006) Guideline on clinical trials in small populations. Doc. Ref. CHMP/EWP/83561/2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003615.pdf . Accessed 24 December 2010