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EU To Tighten Up Some Pharmacovigilance Requirements

Master File & Adverse Event Reporting In The Spotlight

 
• By Ian Schofield

The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.

Concept of health care, medicine, pharmacy, COVID-19, coronavirus. Assortment of pharmaceutical products, white and pink pills with a magnifying glass
Drug safety monitoring is under scrutiny • Source: Alamy

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.

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