Marketing authorization holders in the EU are to be required to strengthen their oversight of pharmacovigilance services subcontracted to third parties and to make more use of the EudraVigilance drug safety database to help improve the evaluation of safety signals, under new proposals from the European Commission.
EU To Tighten Up Some Pharmacovigilance Requirements
Master File & Adverse Event Reporting In The Spotlight
The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.
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