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) 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.
 

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

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

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK