News briefs

Published: 11-Jul-2007
Regulatory Pharmaceutical

The European Medicines Agency (EMEA) has established a new section of its website listing all information relating to its work on paediatric medicines - www.emea.europa.eu/htms/human/paediatrics/introduction.htm.


The European Medicines Agency (EMEA) has established a new section of its website listing all information relating to its work on paediatric medicines - www.emea.europa.eu/htms/human/paediatrics/introduction.htm.

  • It has released a guideline on the clinical development of products for specific immunotherapy for treating allergic diseases - www.emea.europa.eu/pdfs/human/ewp/1850406endraft.pdf;
  • It has also released comments received on draft reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products - www.emea.europa.eu/pdfs/human/pharmacogenetics/1972007en.pdf. For the paper itself - see www.emea.europa.eu/pdfs/human/pharmacogenetics/12851706enfin.pdf;
  • And it has released a concept paper on waiving in vivo bioequivalence studies in favour of specific comparative in vitro testing for biopharmaceuticals - www.emea.europa.eu/pdfs/human/ewp/21303507en.pdf.

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