MHRA's Compliance Report

By Bart Cobert

On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. The MHRA was one of the first of the drug agencies to move to this concept.  Many other agencies, including the FDA, have now also moved to risk based inspections.

The Compliance Report is a document that UK Marketing Authorisation Holders (MAHs) are “encouraged” to complete and file every two years with the MHRA. The first one was requested in 2011. The next one, just announced by this MHRA bulletin, will be released in November, 2013 using a revised format and contents.  It is filled out and submitted electronically on an Excel spreadsheet. It will cover the 2013.

First, a little background on risk based inspections. The MHRA uses information submitted by the MAH as well as the MAH’s previous inspection history, organization change and the “results of intelligence” (MHRA’s term) to determine the amount of “control” an organization has. This is a numerical score. Then a numerical risk score is calculated from the Compliance Report and other information. The risk score is subtracted from the control score and the final number is called the “risk assessment score”.