European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices

News

25/06/2012

European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices

The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today.

The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are:

• 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.

GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients by strengthening the monitoring of the safety of medicines across the EU. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Each module was developed by a team consisting of experts from the Agency and from EU Member States, and was released for public consultation between February and April 2012. The final versions of the modules have been updated, taking the comments received during the public consultation into account. The comments received have also been published today.

On Wednesday 27 June 2012, the Agency will be publishing two further GVP modules for public consultation. These will be:

• Module III: Pharmacovigilance inspections;
• Module X: Additional monitoring.

The remaining seven draft modules making up the entire GVP package are under development and will be released for consultation later in the year.

The GVP modules are aligned with the European Commission’s implementing regulation, published last week. This regulation is a legally binding act that provides details on the operational aspects for the new legislation.

The finalised GVP modules on post-authorisation safety studies and risk management plans refer to the guide on methodological standards in pharmacoepidemiology, which is available on the website of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP). This guide, which was revised last week after an extensive consultation period and expert review, includes methodological guidance for experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review.