The European Medicines Agency has released the first batch of modules on good pharmacovigilance practice (GVP) for public consultation. A total of 7 modules have been released, each covering one major process in the safety monitoring of medicines: Pharmacovigilance systems and their quality systems; Pharmacovigilance systems master files; Risk management systems; Management and reporting of adverse reactions to medicinal products; Periodic safety update reports; Post-authorisation safety studies; Signal management.
The EMA would like to invite ENCePP stakeholders to comment on the practical implementation of the legislation as outlined in these modules, particularly in the GVP module for Post-authorisation safety studies. The deadline for comments is 18 April 2012.
Related information:
- EMA releases good pharmacovigilance practice modules for public consultation
Details
- Publication date
- 28 February 2012
- Author
- European Medicines Agency