EMA releases good pharmacovigilance practice modules for public consultation
The EMA has released the first batch of modules on Good Pharmacovigilance Practices (GVP) for public consultation until 18 april 2012.
GVP is a set of measures drawn up to facilitate the performance of Pharmacovigilance in the European Union. They apply to marketing-authorization holders, the Agency and medicines regulatory authorities in EU member states and aim to improve safety for patients by strengthening Pharmacovigilance across the EU. They cover medicines authorized centrally via the agency as well as medicines authorized at the national level.
GVP covers following aspects of 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-authorization safety studies
Module IX: Signal management
The release of these modules is a key deliverable of the 2010 Pharmacovigilance legislation, which will apply from july 2012. Each module was developed by a team consisting of experts from the agency and from EU member states.
The Agency is seeking comments on the practical implementation of the legislation as outlined int these modules. The underlying legal requirements cannot be altered through this consultation process.
Agency intends to finalize and publish these modules by July 2012, after comments from stakeholders have been taken into account.
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