Regulatory Focus™ > News Articles > EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee

EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee

Posted 26 July 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) announced today (26 July) the release of two additional guidelines on good pharmacovigilance practices (GPhVPs) and the shuttering of its Pharmacovigilance Working Party.

In a statement, the agency said the working party has been phased out of its original charge-given to it at the time of the agency's founding in 1995-to provide advice on the safety of medicines. Its duties will now be absorbed by a newly-established Pharmacovigilance Risk Assessment Committee (PRAC), which EMA noted was a "main deliverable" of the 2012 pharmacovigilance legislation.

A list of new members involved with the PRAC did not return any members previously on the PhVWP.

In addition to announcing the final report of the PhVWP, EU regulators also said they had released the two additional Guidelines on GPhVPs: Module XV on safety communication and Module IV on pharmacovigilance audits.

Both guidelines are scheduled to come into effect in December 2012, with comments due by 21 December 2012. A further five guidelines are scheduled to be released by the end of 2012, EMA said in a statement.


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