EMEA news in brief

Published: 3-Apr-2007


  • The European Medicines Agency (EMEA) has released a survey into the 2006 performance of its scientific procedures for human medicinal products - www.emea.eu.int/pdfs/general/direct/48948206en.pdf;
  • It has also issued a report on benefit-risk assessment models and methods for human medicines - www.emea.eu.int/pdfs/human/brmethods/1540407en.pdf;
  • And it has published advice on developing new medicines treating Crohn's disease - www.emea.eu.int/pdfs/human/ewp/228499.pdf;
  • EMEA has also released revisions to its guideline on the clinical development of medicinal products for treating HIV -www.emea.eu.int/pdfs/human/ewp/4206507en.pdf;
  • And the agency has recommended changes to requirements for clinical documentation regarding orally inhaled medicines - www.emea.eu.int/pdfs/human/ewp/4423807en.pdf.
  • Elsewhere, the European Commission has released a guideline on reviewing market exclusivity periods for orphan medicinal products - http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2007/2007_03/draft_guideline_art8-2_200702.pdf

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