Monday 3 June 2013

What is Pharmacovigilance? An introduction

This is part of an occasional series of educational posts. This post looks as Pharmacovigilance, from an EU GMP perspective.


The legal framework for pharmacovigilance for medicinal products in the EU/EEA is set out in a number of Directives, which describe the obligations of Marketing Authorisation Holders and the Regulatory Authorities. This requires them to set up a system for pharmacovigilance in order to:
  • Collect, collate and evaluate information about reported and suspected adverse reactions 
  • Share relevant information to allow all parties involved to meet their obligations and discharge their responsibilities.
Information about drug safety is obtained from a number of sources including:
  • Spontaneous adverse drug reaction (ADR) reporting schemes, for example, the UK’s “Yellow Card” Scheme. 
  • Clinical studies and investigation of health and diseases in wider populations. 
  • Information from pharmaceutical companies and information published in medical literature. 
  • Information from regulatory authorities worldwide and from morbidity and mortality databases. 
Marketing authorisation holders are required to operate a system to monitor and report back to the authorities on the safety of their products. This requires the collection and reporting of spontaneous safety events and the collection and evaluation of safety data from various sources over the life of a medicine. For new products this is defined in a pharmacovigilance plan that is part of the risk planning information that accompanies an application for a marketing authorisation.

The MAH is required to have a documented system and the resources needed to meet these obligations and also to provide pharmacovigilance “Qualified Person” (which should not be confused with the Qualified Person responsible at a manufacturing site for batch certification).

The responsibilities of the DRAs of the EU Member States with regard to pharmacovigilance involve:
  • The assessment of safety data and plans for marketed medicinal products. 
  • The inspection of MAH pharmacovigilance systems. 
  • The communication of safety information to stakeholders. 
  • Taking necessary actions to prevent or mitigate safety problems (e.g. by the suspension of a marketing authorisation or by changes to therapeutic indications). 
  • Entering safety information in a European Pharmacovigilance database (EudraVigilance). 
Further information can be found in either EudraLex Volume 9 at the reference given above. This contains guidelines for both human and veterinary pharmacovigilance.

Information on the MHRA’s Pharmacovigilance System can be found at:


Posted by Tim Sandle

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