EMA Asks for Feedback on Pharmacovigilance Legislation Implementation

Posted 05 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is calling on industry to comment on its draft list of European Union reference dates for Period Safety Update Reports (PSURs) that are being implemented as a result of the recent pharmacovigilance legislation.

"The purpose of the consultation is to ensure completeness and correctness of the information before the list is adopted later this year," said EMA in a prepared statement released 4 April.

"The list is intended to optimize the management of PSURs assessment within the EU while supporting transparency," explained EMA. "It aims to provide predictability to the various stakeholders in terms of workload related to PSURs taking into account the currently-known safety profile of the active substances and combination of active substances. "

The draft list is available on EMA's website, and the consultation is available until 4 June 2012.

[Editor's note: EMA's website is down for scheduled maintenance on 5 April 2012. It should be operational again by 5:30 PM GMT on 5 April.]

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EMA - Feedback requested on the draft list of European Union Reference Dates for Periodic Safety Update Reports in preparation for introduction of the new pharmacovigilance legislation

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