The new European regulation on pediatric medicines: Regulatory perspective

Pediatric Drugs

Volumn 10, Issue 3, 2008, Pages 143-146

  Hawcutt, Daniel B ^a   Smyth, Rosalind L ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Children; Regulatory process

Indexed keywords

GENERIC DRUG; ORPHAN DRUG;

CHILD; DRUG EFFICACY; DRUG SAFETY; DRUG UTILIZATION; EDITORIAL; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; LAW; PATENT; PRIORITY JOURNAL; PROFIT;

CHILD; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MARKETING OF HEALTH SERVICES; PEDIATRICS;

EID: 43049093351     PISSN: 11745878     EISSN: None     Source Type: Journal    
DOI: 10.2165/00148581-200810030-00002     Document Type: Editorial

References (17)

1. EU regulation (EC) No 1901/2006 of the European Parliament and of the council of 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. 2007
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: clinical investigation of medicinal products in the pediatric population. E11. Current step 4 version, 20 July 2000 [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA487.pdf [Accessed 2008 Feb 21]
3. Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. Br Med J 2000; 320: 79-82
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10. European Union. Proposal for a regulation of the European Parliament and of the council on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, Directive 2001/83/EC and regulation (EC) No 726/2004. Available from URL: http://register.consilium.europa.eu/pdf/en/04/st13/st13/ st13880.en04.pdf [Accessed 2008 Apr 4]
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