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.
You may also be interested in...
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.
EMA Makes "Steady Progress" On Revising Pharmacovigilance Guideline For Pediatric Drugs
The European Medicines Agency is revising its guideline on pharmacovigilance requirements for pediatric drugs to show how drug development plans can benefit from the new pharmacovigilance environment in both scientific and regulatory terms.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.