EU News Briefs

Published: 20-Oct-2006


  • The European Medicines Agency (EMEA) has published a template for producing risk management plans in the pharmaceutical industry - http://www.emea.eu.int/pdfs/human/euleg/19263206en.pdf;
  • EMEA has also released a revised checking process for mock-ups and specimens of outer/immediate labelling and packaging leaflets - http://www.emea.eu.int/pdfs/human/regaffair/30582106en.pdf;
  • It has advised on documents required for simplified medicine registration referrals - http://www.emea.eu.int/pdfs/human/hmpc/43112905en.pdf;
  • And it has released proposals on its publication of negative opinions to marketing authorisation applications - http://www.emea.eu.int/pdfs/human/euleg/31135505en.pdf.
  • Meanwhile, the European Commission has released guidelines on ethical considerations for clinical trials performed on children - http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/paeds_ethics_consultation20060929.pdf

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