Legislation
Europe
Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMEA). Druft guideline on clinical trials in small populations. CHMP/EWP/83561/2005. London: EMEA. 2005
Proposal for a Regulation of the European Parliament and of the Council.
EMEA. Work Programme for the Paediatric Expert Group (PEG) 2004-2005
European Commission. Regulation of the European Parliament and Council on medicinal products for paediatric use. Draft for public consultation. 2004.
European Commission. Medicine for Children. On 29 September 2004 the European Commission adopted a proposal for a Regulation of the Council and of the Parliament on Medicinal Products for Paediatric Use.
EMEA. Concept Paper on the Development of Committee for Proprietary Medicinal Products (CPMP) Guidance on Formulations of Choice for the Paediatric Population. 2003
EMEA. Medicines for Children - The European Paediatric Initiative. July 2003.
EMEA. Work Programme for the Paediatric Expert Group (PEG) 2003
European Commission. Better Medicines for Children. Proposed regulatory actions on paediatric medicinal products. Brussels, February, 2002.
Directive 2001/20/EC Of The European Parliament And Of The Council Of 4 April 2001
EMEA. CPMP Paediatric Expert Group (PEG). Concept paper on the mandate, composition and functioning of the group. June 2001. CPMP/14691/01 rev.1.
EMEA. ICH Topic E11. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population. 1999
EMEA. CPMP. Note for Guidance on the Clinical Investigation of Medicinal Products in Children. 1997
The Nuremberg Code (1947). BMJ 1996;313:1448.
E11 Clinical Investigation of Medicinal Products in the Pediatric Population. Guidance for Industry
EMEA. ICH topic E11: Note for Guidance on Clinical Investigation of medicinal products in the paediatric population. 2001.
European Commission. Better Medicines for Children. Proposed regulatory actions on paediatric medicinal products. Brussels, Frebruary, 2002.
European Commission. Proposal for a Regulation of the European Parliament and of the Council on medicinal products for paediatric use. 2004
United States
US Department of Health and Human Services. Protection of Human Subjects- Title 45 Code of Federal Regulations Part 46, 1981. Revised June 23, 2005.
US Department of Health and Human Services. Protections of Human Subjects- Title 45 Code of Federal Regulations Part 46, Subpart D - Additional protections for children involved as subjects in research, 1983. Revised June 23, 2005.
Fair Access to Clinical Trials Act of 2004, H.R. 5252, 108th Cong., 2d Sess.
Department of Health and Human Services, United States Food and Drug Administration. Statement of the FDA Commissioner Mark B. McClellan, M.D., Ph.D., on the signing of the Pediatric Research Equity Act of 2003. 3 Dec 2003.
United States Pediatric Research Equity Act of 2003
Best Pharmaceuticals for Children Act, Pub. L. 107-109 (Jan. 4, 2002).
Civil Action - AAPS vs FDA on Pediatric Rule. 2002
The Pediatric Exclusivity Provision. Status Report to Congress. January 2001
US Department of Health and Human Services, Food and Drug Administration. Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products. Federal Register 2001;66(79):20589
Children's Health Act of 2000. Pub. L. 106-310 (Oct 17, 2000)
US Department of Health and Human Services. Protections for Children in Research: A Report to Congress in Accord with Section 1003 of PL 106-310, Children's Act of 2000.
US Department of Health and Human Services, Food and Drug Administration. regulations requiring manufactures to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Federal Register. 1998;63:66632
US Department of Health and Human Services, Food and Drug Administration. Druft guidance for industry: General considerations for pediatric pharmacokinetic studies for drugs and biological products. 1998
Food and Drug Modernization Act of 1997 (FDAMA). (See Section 111: Pediatric studies of drugs)
US Department of Health and Human Services, Food and Drug Administration. Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of ``Pediatric Use'' Subsection In the Labeling. Federal Register. 1994;59:64240
Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics.
Pediatrics. 1995 Feb;95(2):286-94.
International Conference on Harmonization (ICH). E11 Clinical Investigation of Medicinal Products in the paediatric Population. December 2000
Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Final Rule
International
World Medical Association. Declaration of Helsinki. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and later amended. (last version Tokyo 2004).
The Nuremberg Code (1947). BMJ 7 December 1996;313:1448.