Good Pharmacovigilance Practice and the Curate’s Egg

Excerpt

In February this year, the European Medicines Agency (EMA) placed on the Internet the first seven Good Pharmacovigilance Practice (GVP) modules, out of a full set of 16, for public consultation; the remainder will be available over the next few months.[1] The consultation time is over, and I did not make any comments directly for reasons that are clear: the size and complexity of the documents; the cross referencing needed for consistency in the details; and that there is less than half of the full GVP available now. The GVP is coincident with new, important EU Directives (Directive 2010/84/EU)[2] and Regulations (Regulation [EU] No 1235/2010)[3] amending existing legislation that were adopted in the EU in December 2010. These are comprehensive developments in pharmacovigilance (PV) and need serious, critical reflection. …