The European Regulation on medicines for paediatric use

References 

1. Section 111 of Title I of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). http://www.fda.gov/cder/guidance/2891fnl.htm#ATTACHMENT%20A
2. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients (“Pediatric Rule”), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed. Reg. 66,632 (December 2, 1998).
3. Best Pharmaceuticals for Children Act. http://www.fda.gov/opacom/laws/pharmkids/pharmkids.html.
4. Pediatric Research Equity Act of 2003, http://www.fda.gov/cder/pediatric/S-650-PREA.pdf.
5. Report on the Experts’ Round Table on the Difficulties Related to the Use of New Medicinal Products in Children Held on 18 December 1997. http://www.emea.eu.int/pdfs/human/regaffair/2716498en.pdf
6. Council Resolution on Paediatric Medicinal Products, 14 December 2000, J.O. C-17, 19/01/2001. http://europa.eu.int/eur-lex/en/archive/2001/c_01720010119en.html
7. Proposal for a Regulation of the European Parliament and Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004. http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/_2004_09/en.pdf.
8. Regulation (EC) No.141/2000 of the European Parliament and of the Council on Orphan Medicinal Products (Official Journal L 18, 22/1/2000, pp. 1–5). http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/141_2000/141_2000_en.pdf
9. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99). http://www.emea.eu.int/pdfs/human/ich/271199en.pdf
10. Ethical Considerations for Clinical Trials Performed in Children. Recommendations of the Ad Hoc Group for the Development of Implementing Guidelines for Directive 2001/20/EC Relating to Good Clinical Practice in the Cconduct of Clinical Trials on Medicinal Products for Human Use. http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/paeds_ethics_consultation20060929.pdf
11. 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 (Official Journal L 121, 1/5/2001, pp. 34–44). http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf