MHRA Drops Pharmacovigilance Compliance Reporting Requirements

Posted 26 July 2016 By Michael Mezher


The UK's Medicines and Healthcare products Regulatory Agency (MHRA) says it no longer wants drugmakers to submit regular drug safety surveillance compliance reports, unless they are specifically requested by the agency.

Previously, MHRA used the reports as a factor in its risk-based inspection scheme, at times basing pharmacovigilance inspections on companies' responses to the report questionnaire.

While the compliance reports were not mandatory, MHRA said that companies who did not submit them would be given a high-risk rating for the purposes of inspection scheduling.

"We have used the data provided in these reports to support our inspection scheduling and planning activities. In addition, we have used the reports to enhance the information that we maintain on our inspection universe by understanding the number of pharmacovigilance systems in operation in the UK," MHRA writes.

The agency made the announcement in an update to the good pharmacovigilance practice (GPvP) page on its website on Monday, saying, "As of 2016, we no longer require routine compliance reports to be submitted as we now have access to a variety of information sources that can support our scheduling and planning activities."

Going forward, MHRA says it will contact companies directly if it requires information about their authorized products and pharmacovigilance systems.

However, other aspects of pharmacovigilance practice and reporting will not be affected by the move to halt routine compliance reporting, as MHRA plans to continue its risk-based inspections program using other data to inform scheduling priority.

According to MHRA's most recent Pharmacovigilance Inspection Metrics Report, which covers inspections between April 2014 and March 2015, the agency carried out a total of 48 pharmacovigilance inspections. The bulk of which were routine re-inspections (21) or routine first time inspections (15), while only 10 were inspections triggered by a specific issue.


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Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, Europe, MHRA

Tags: Pharmacovigilance, GPvP, GVP

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