EMA Finalizes Pharmacovigilance Guidelines

Jun 28, 2012

The European Medicines Agency (EMA) has published its first set of finalized guidelines concerning good pharmacovigilance practices (GVP). The guidelines are a key deliverable of Europe’s pharmacovigilance legislation, which will come into effect on July 2, 2012.

Several modules make up the GVP package. Seven modules have been finalized so far concerning pharmacovigilance systems and their quality systems, pharmacovigilance systems’ master files, risk-management systems, management and reporting of adverse drug reactions to medicinal products, periodic safety update reports, postauthorization safety studies, and signal management.

Each module was released for consultation between February and April 2012 and the final versions reflect some of the comments received. Each module was developed by a team of experts from the EMA and EU member states.

More modules are also under development, including modules for pharmacovigilance inspections and additional monitoring, and will be released for consultation later in the year.