TITLE

"Bonne Année", "Gutes Neues Johr"? Will 2007 be a "Happy New Year" for children's medicines in Europe?

AUTHOR(S)
Stephenson, T.
PUB. DATE
August 2007
SOURCE
Archives of Disease in Childhood;Aug2007, Vol. 92 Issue 8, p661
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article discusses a new European Union (EU) pediatric legislation, which focuses on encouraging more research on pediatric medicines. The legislation's proposals include incentives to encourage pharmaceutical industries to test products for use in children and the establishment of a committee to assess pediatric investigation plans for developing medicines. It also involves forming European clinical trial networks to promote collaboration on pediatric studies and adding a special label on medicines licensed for pediatric use.
ACCESSION #
26292110

 

Related Articles

  • A brave new Europe with the introduction of the EU Clinical Trials Directive: Impact upon the pharma industry and academic research with special emphasis on pharmacovigilance. Ladds, Graeme // Journal of Commercial Biotechnology;Oct2004, Vol. 11 Issue 1, p44 

    1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implementing the Directive nationally at the same time and all being affected by the many and varied aspects covered in the Directive....

  • EU Questions Get Real EU Answers. O'Donnell, Peter // Applied Clinical Trials;Jun2006, Vol. 15 Issue 6, p34 

    The article reports on the updates of European Union's question and answer guide for clinical medicine practitioners. One of the updates include the algorithm to help define when development work on a product goes with the rules governing clinical trials of pharmaceutical drugs. Generally, it...

  • Change the CT Rules, but to What, Precisely? O'Donnell, Peter // Applied Clinical Trials;Aug2011, Vol. 20 Issue 8, p20 

    In this article, the author discusses the effort of the European Union (EU) to revise the legislation on its clinical trials (CT) rules. The author mentions that the Union's staff is working on an assessment on what sort of change is needed. He also talks about the concerns of many clinical...

  • Industry Squirms Under Antitrust Spotlight. O'Donnell, Peter // Applied Clinical Trials;Aug2008, Vol. 17 Issue 8, p32 

    The article reports on the slowdown in new drugs to market prompting an investigation by the European Union (EU) authorities. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), that one reason behind the reduced ratio of the pharmaceutical industry is the...

  • Legislation on child-safe medicine set to roll out. Odriscoll, Cath // ICIS Chemical Business;6/12/2006, Vol. 1 Issue 23, p47 

    This article focuses on a new medical legislation in Europe. More than 50% of medicines used to treat children in Europe remain untested and unauthorised for used in children, severely restricting the choice of drugs prescribed by doctors. The new legislation is intended to change this, by...

  • Research bodies lobby EU governments over trials legislation. Watson, Rory; Eaton, Lynn // BMJ: British Medical Journal (International Edition);11/1/2003, Vol. 327 Issue 7422, p1010 

    Reports that research organisations across Europe are joining forces to lobby their national authorities to ensure that EU legislation on clinical trials will be implemented as flexibly as possible when it comes into force next May. Fears that the terms of the directive could reduce the scope...

  • Drug group goes public with studies. Acosta, Kim; Kritz, Frank // Shape;Feb2005, Vol. 24 Issue 6, p92 

    The article reports that clinical studyresults.org, a new website created by PhRMA, contains the results of all clinical trials, both positive and negative, for member-company, PDA-approved drugs since October 2002. Critics say the new site still falls short. Senator Edward M. Kennedy has...

  • The New European Regulation on Pediatric Medicines: Regulatory Perspective. Hawcutt, Daniel B.; Smyth, Rosalind L. // Pediatric Drugs;2008, Vol. 10 Issue 3, p143 

    The article focuses on the new regulation for pediatric medicine introduced by the European Union (EU) in January 2007. The authors outline the incentives and requirements for pharmaceutical companies instituted by the regulation. Those measures include requiring companies to submit a pediatric...

  • The New European Regulation on Pediatric Medicines: Safety and Ethics Perspectives. Neubert, Antje; Planner, Claire; Cranswick, Noel // Pediatric Drugs;2008, Vol. 10 Issue 3, p147 

    The article examines the safety and ethical implications of the Paediatric Regulation introduce by the European Union (EU) on January 26, 2007. The regulation's safety and ethical implications were analyzed with regard to pediatric medicine development, the conduct of clinical trials...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics