Virtual Pharmacovigilance Inspections

By Bart Cobert

On January 18 of this year the UK Medicines and Healthcare Products Regulatory Agency (MHRA) released a short new document from the Office of Compliance and Inspection covering Distant/Virtual pharmcovigilance (PV) inspections of Marketing Authorization Holders (MAHs) during a crisis situation.

For some time now the MHRA has indicated that it may do routine “virtual” or “distance” PV inspections of MAHs. In a July Q&A http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/Frequentlyaskedquestions/index.htm in question 7, the MHRA indicated that it might do a distance inspection if the MAH does not have a UK site: “…then a ‘virtual’ inspection may be performed. This may involve the MAH hiring temporary office space in the UK, or alternatively, the inspection being performed via teleconferences.”

The UK inspection process is a complicated one consistent with other EU PV inspections. In a nutshell, the MHRA contacts the MAH (or inspectee) and indicates they want to do a PV inspection. A date is agreed upon and a large amount of information describing the PV system, approved/authorized products and other company details is sent usually on a CD or DVD. A document called the Summary of PV Systems is also prepared and sent. The MAH may then decide to do or not do the inspection based on the data received. If they do decide on an on-site inspection, then the inspection unfolds as expected. Alternatively they may be satisfied with the data received and doing additional teleconferences or videoteleconferences” – a virtual inspection.