Pharmacovigilance: EU concept paper

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission’s 2010 amended pharmacovigilance legislation.

The concept paper details several topics including:

pharmacovigilance system master files
the quality system for the performance of pharmacovigilance activities
the use of internationally agreed terminology, formats, and standards
monitoring data in the EudraVigilance database
the electronic transmission of suspected adverse reactions
electronic periodic safety update reports and risk-management plans
postauthorization safety studies.