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The British Medicines and Healthcare products Regulatory Agency (MHRA) has
recently published their pharmacovigilance inspection metrics reports for
the year 2006. These two 6-months reports give a good overview of regulatory
enforcement activities with respect to pharmacovigilance surveillance - not
only for UK based companies.
In the 2006 reports, the pharmacovigilance inspectorate
listed a total of 32 critical findings during the year. The majority of
critical findings related to overall failure of the pharmacovigilance
system, spontaneous case processing and the roles and responsibilities of
the EEA Qualified Person for Pharmacovigilance (QPPV). Also, the largest
number of major findings was related to these topics. However, it can be
seen that there were findings in all areas of inspections.
The 2006 reports can be found here:
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=964
Guidance on Pharmacovigilance inspections is provided in
Chapter 2.4 of part 1 of
Volume 9A Pharmacovigilance (Human) of the Rules
Governing Medicinal Products in the European Union. The guideline addressing
veterinary products is available as a stand alone document in the
Volume 9B
section of Volume 9.
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