EMA Finalizes Pharmacovigilance Practice Guidelines

Posted 25 June 2012 | By Alexander Gaffney

The European Medicines Agency (EMA) has released seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be-implemented pharmacovigilance (PV) legislation, which comes into effect 2 July 2012.

The modules cover a variety of topics, including PV systems, PV quality systems, risk management systems, PV system master files, Periodic safety update reports (PSURs), postmarketing safety studies and adverse event reporting.

EMA said in a statement on 25 June that the GVP modules had been formed with the help of experts from EMA and European member states. Two additional GVP modules detailing pharmacovigilance inspections and additional monitoring procedures (Modules II and X) will be released on 27 June 2012, the agency announced.

Also complementing the release of the modules is a checklist released by EMA detailing the implementation status of various aspects of the PV legislation, of which roughly half the tasks are still listed as "ongoing" rather than "completed," though the majority of those not yet completed are of secondary importance.


Read more:

Guideline on good pharmacovigilance practices: Module I - Pharmacovigilance systems and their quality systems  (25/06/2012)

Guideline on good pharmacovigilance practices: Module II - Pharmacovigilance system master file (25/06/2012)

Guideline on good pharmacovigilance practices: Module V - Risk management systems  (25/06/2012)

Guideline on good pharmacovigilance practices: Module VI - Management and reporting of adverse reactions to medicinal products (25/06/2012)

Guideline on good pharmacovigilance practices: Module VII - Periodic safety update report  (25/06/2012)

Guideline on good pharmacovigilance practices: Module VIII - Post-authorisation safety studies (25/06/2012)

Guideline on good pharmacovigilance practices: Module IX - Signal management  (25/06/2012)

European Medicines Agency and Member States joint implementation check-list (25/06/2012)

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