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EMA Pilot To Help Companies ‘Ease In’ To New EudraVigilance System

 
• By Vibha Sharma

The European Medicines Agency will use a phased approach to help companies comply with their obligation to monitor the revamped EU pharmacovigilance database and to report validated signals. Under a pilot to be launched on Feb. 22, 2018, companies will only have to monitor and report signals on drugs under additional monitoring.

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EudraVigilance Pilot Will Focus On Drugs Under Additional Monitoring • Source: Shutterstock

The European Medicines Agency is planning a one-year pilot as part of a phased approach to help drug companies comply with new obligations to monitor the revamped EU pharmacovigilance database (EudraVigilance) when it goes live on Nov. 22 and to communicate all validated signals to the agency and national competent authorities.

The EMA and the European Commission have agreed that the new pharmacovigilance obligations being introduced for marketing authorization holders (MAHs)...

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