Reactions 1408 - 30 Jun 2012

EMA wraps up first set ofguidelines on GVP

The first set of finalised modules of the guideline ongood pharmacovigilance practices (GVP) has beenreleased by the EMA.

GVP is designed to facilitate the performance ofpharmacovigilance in the EU, and the finalisation of thefollowing modules represents a key step in complyingwith the 2010 pharmacovigilance legislation, to takeeffect on 2 July 2012.• Module I: Pharmacovigilance systems and their

quality systems.• Module II: Pharmacovigilance systems master files.• Module V: Risk management systems.• Module VI: Management and reporting of adverse

reactions to medicinal products.• Module VII: Periodic safety update reports.• Module VIII: Post-authorisation safety studies.• Module IX: Signal management.The GVP guideline applies to the EMA and medicines

regulatory authorities in EU member states, and tomarketing authorisation holders, and through enhancingthe monitoring of safety of medicines across the EU,aims to improve patient safety. Medicines authorisedcentrally by the EMA are covered in GVP, in addition tomedicines authorised at the national level.

Two more draft modules will be published this weekfor public consultation, and a further seven draftmodules are under development and will be issued forconsultation later this year; this will complete the entireGVP package.EMA. European Medicines Agency finalises first set of guidelines on goodpharmacovigilance practices. Internet Document : [1 page], 25 Jun 2012. Availablefrom: URL: http://www.ema.europa.eu 803072925

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