Industry Underwhelmed By EMA Pediatrics Pharmacovigilance Guide Update Plans
Executive Summary
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.
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Global Pharma Guidance Tracker – March 2024
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