Regulatory Focus™ > News Articles > Additional Pharmacovigilance Guidelines Released by EMA

Additional Pharmacovigilance Guidelines Released by EMA

Posted 27 June 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released its final two guidelines on good pharmacovigilance practices (GVPs) after releasing seven similar GVP guidelines on 22 June.

The final two guidelines address modules III and X of proposed GVPs: pharmacovigilance inspections and additional monitoring, respectively.

The first guideline, Pharmacovigilance Inspections, provides guidance on planning, conducting, reporting and following-up on pharmacovigilance inspections in the EU, including the roles for regulatory affairs staff.

The second guideline, Additional Monitoring, provides guidance on how to detect and respond to "potential safety hazards" involving medicinal products as rapidly as possible.

Both guidelines are in a public consultation phase until 24 August 2012, after which time European regulators will move to implement them. EMA said it anticipates the two guidelines coming into effect in the fourth quarter of 2012 after being finalized.

In a statement, EMA said an additional seven guideline modules will be published by the end of 2012, for a total of 16 GVP guidelines. The first set of seven guidelines have already been published and finalized, and will come into effect on 2 July 2012.


Read more:

EMA - Two modules of guideline on good pharmacovigilance practices released for public consultation


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