EMEA PHARMACOVIGILENCE
September 1st, 2005
BY KEITH NUTHALLA PUBLIC consultation exercise has been launched by the European Medicines Agency (EMEA) on a draft guideline over the pharmacovigilence for medicines used by babies, children and young people aged up to 18. The agency is grappling with European Commission concerns that more than 50% of medicines used to treat children are prescribed on an unlicensed or 'off-label' basis, because they have not been adequately tested, formulated and authorised for them. The EMEA guideline would be used to help companies implement the incoming EU regulation on ...
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