Medicines for children: Time for Europe to act

Paediatric and Perinatal Drug Therapy

Volumn 6, Issue 3, 2005, Pages 142-146

  Saint Raymond, Agnès ^a   Seigneuret, Nathalie ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Children; EMEA; European Commission; European Union; Marketing authorisation; Medicines; Orphan drug; Regulation on medicinal products for paediatric use

Indexed keywords

ORPHAN DRUG;

CHILD; CHILD HEALTH CARE; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; EUROPE; EUROPEAN UNION; HUMAN; OFF LABEL DRUG USE; PATENT; PEDIATRICS; PRACTICE GUIDELINE; PROTECTION; PUBLICATION; REVIEW; REWARD;

EID: 29144529634     PISSN: 14630095     EISSN: None     Source Type: Journal    
DOI: 10.1185/146300905X39361     Document Type: Review

References (15)

1. Turner S, Nunn AJ, Fielding K et al. Adverse drug reactions to unlicensed and off label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965-968.
2. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54: 665-670.
3. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Agency for the evaluation of Medicinal Products. (Official Journal L 214, 24.08.1993, pp.1-21).
4. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30.04.2004, pp. 1-33).
5. Food and Drug Administration: http://www.fda. gov/oc/opt/default.htm
6. Proposal for a Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Council Regulation (EEC) no 1786/92, Directive 2001/83/EC and Regulation (EC) No 726/2004: http://pharmacos.eudra.org/F2/Paediatrics/index.htm
7. European Medicines Agency Human Medicines Evaluation Unit; Committee for Proprietary Medicinal Products. Note for guidance on clinical investigation of medicinal products in children 1997 (www.emea.eu.int).
8. t'Jong GW, Stricker BHCh, Choonara I, van den Anker JN. Lack of effect of the European guidance on clinical investigation of medicines in children. Acta Paediatr 2002; 91: 1233-1238.
9. (EMEA/27164/98 Revision 1 Report on the Experts Round Table on the Difficulties related to the Use of New Medicinal Products in Children).
10. Proposal for a Regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Council Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 - http://pharmacos.eudra.org/F2/Paediatrics/docs/_2004_ 09/EN.pdf
11. http://pharmacos.eudra.org/F2/Paediatrics/docs/ Extended%20Impact%20Assessment%20final% 203%20September.pdf
12. http://www.fda.gov/cder/pediatric/
13. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Official Journal L 18, 22.01.2000 pp. 1-5).
14. 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, 01.05.2001 pp. 34-44).
15. Commission consultation on a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for paediatric use: http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/mar/ Paediatric%20consultation%20doc ument%20final%208%20March%2004.pdf