Good Pharmacovigilance Practice: News

Frequently asked questions page - 16 March 2009
Two new questions and answers have been added under the miscellaneous section.
› Frequently asked questions

Inspection metrics 2008
The pharmacovigilance inspection metrics reports for 2008 are now available. Any feedback on the layout, content or any other comments that you may have on these reports can be sent to the Pharmacovigilance Inspectorate Unit (see main Good Pharmacovigilance Practice webpage for contact details).

Pharmacovigilance inspection metrics reports:
› January to June 2008 (74Kb)
› July to December 2008 (71Kb)

The Good Pharmacovigilance Practice Guide
The eagerly awaited Good Pharmacovigilance Practice Guide is now available. For further information and to order a copy please visit the Pharmaceutical Press website www.pharmpress.com/9780853698340 (external site).

Pharmacovigilance for Herbal Marketing Authorisations and Traditional Herbal Registrations Seminar
On 25 September 2008 the MHRA held a successful Pharmacovigilance for Herbal Marketing Authorisations and Traditional Herbal Registrations Seminar. We hope to hold additional events such as these in the future.

For the latest information please visit our Conference and Education section

Common inspection findings
Some common inspection findings and current areas of concern that have been identified during recent inspections have been included on the Good Pharmacovigilance Practice page under the 'Grading of inspection findings' section.

› Common inspection findings (386Kb)

Pharmacovigilance Service Desk
The MHRA has launched a Pharmacovigilance Service Desk which is to be the first port-of-call for marketing authorisation (MA) holders and their representatives, enquiring about any pharmacovigilance related matters and any associated regulatory activity.

› Pharmacovigilance Service Desk: Providing a service to marketing authorisation (MA) holders

Feedback from Industry on GPvP Inspections
During 2005 a pilot project took place to obtain feedback from industry on the conduct of pharmacovigilance inspections. Organisations taking part were invited to score their responses to fifteen questions of a non-technical nature and to provide comments on the five phases of the inspection process. This project was extended in 2006 to a larger number of inspected organisations. The questions were the same as previously, with an additional one asking if the organisation had benefited from the inspection. 

› Good Pharmacovigilance Practice inspection questionnaire - Analysis of returns (18Kb)

Inspection metrics 2007
The pharmacovigilance inspection metrics reports for 2007 are now available. Any feedback on the layout, content or any other comments that you may have on these reports can be sent to the Pharmacovigilance Inspectorate Unit (see main Good Pharmacovigilance Practice webpage for contact details).

Pharmacovigilance inspection metrics reports:
› January to June 2007 (73Kb)
› July to December 2007 (118Kb)

Inspection metrics 2006
The pharmacovigilance inspection metrics reports for 2006 were presented at the Edinburgh Pharmacovigilance Symposium on 8 March 2007.  The metrics provide information on the number and type of MAHs inspected, the areas associated with common inspection findings, as well as the number of critical, major and other findings.

Pharmacovigilance inspection metrics reports:
› January to June 2006 (74Kb)
› July to December 2006 (71Kb)

You can now receive an e-mail alert to inform you when updates are made to the Good Pharmacovigilance Practice (GPvP) pages of the MHRA website. If you currently subscribe to our e-mail alerting service you will need to update your preferences to include the GPvP section. You can register to receive MHRA e-mail alerts by visiting our E-mail alerting service section.