Good Vigilance Practice
The European Medicines Agency (EMA) has published a first tranche of modules of the Good Vigilance Practice (GVP) guide for public comment.
In detail, these are the following seven chapters, each covering one of the main aspects of the drug safety system:
- 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.
GVP is a guideline developed in connection with the 2010 pharmacovigilance legislation (effective July 2012). It specifies and standardizes the requirements for the European drug safety system. The requirements apply to both marketing authorization holders and the EMA itself, as well as to the national authorities of the member states, and aim to optimize patient safety for all medicinal products, regardless of the type of marketing authorization. Each of the modules has been developed by a dedicated team of experts from EMA and Member States.
With this publication, EMA invites all relevant stakeholders to comment on these documents. However, the underlying legal provisions remain unaffected by this consultation process.
Finalization of the guidance document is scheduled for July 2012 after consideration of the comments received. The consultation process for nine additional modules will follow during 2012.
Comments:
Comments should be emailed to EMA at gvp@ema.europa.eu by April 18, 2012.
More information:
