MHRA Publishes Pharmacovigilance Inspection Metrics Reports for 2006

GMP News
26 July 2007

MHRA Publishes Pharmacovigilance Inspection Metrics Reports for 2006

The British Medicines and Healthcare products Regulatory Agency (MHRA) hasrecently published their pharmacovigilance inspection metrics reports forthe year 2006. These two 6-months reports give a good overview of regulatoryenforcement activities with respect to pharmacovigilance surveillance - notonly for UK based companies.

In the 2006 reports, the pharmacovigilance inspectoratelisted a total of 32 critical findings during the year. The majority ofcritical findings related to overall failure of the pharmacovigilancesystem, spontaneous case processing and the roles and responsibilities ofthe EEA Qualified Person for Pharmacovigilance (QPPV). Also, the largestnumber of major findings was related to these topics. However, it can beseen that there were findings in all areas of inspections.

The reports can be found here:


Guidance on Pharmacovigilance inspections is provided inChapter 2.4 of part 1 ofVolume 9A Pharmacovigilance (Human) of the RulesGoverning Medicinal Products in the European Union. The guideline addressingveterinary products is available as a stand alone document in theVolume 9Bsection of Volume 9.

Hear essential aspects about the handling and management ofcomplaints, pharmacovigilance issues and recalls at the ECA Education Course

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


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