EMA Proposes New Pediatric-Specific Pharmacovigilance Requirements
The European Medicines Agency has proposed replacing its current guideline on pharmacovigilance of pediatric medicines to address the various scientific and regulatory developments that have taken shape over the last 10 years.
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By the time it is released early this year, it will have taken nearly three years for the European Medicines Agency's guideline on pharmacovigilance requirements for paediatrics to be updated. The agency’s proposals have failed to impress the pharmaceutical industry, which says among other things they contain little new information.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.
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