GVP Updates

The European Medicines Agency (EMA) released the 3rd revision of Good Pharmacovigilance Practices (GVP) Module XVI on risk minimization measures. The date of coming into effect was 6 August 2024. The revised final guidance is applicable to

• New marketing authorization applications
• New risk minimisation measures (RMMs) 
• New studies evaluating risk minimization measures for authorized medicinal products

The document is not immediately applicable to existing RMMs and ongoing activities regarding RMMs. However, where existing RMMs are amended, the revised guidance should be taken into account and applied if this is considered to increase the effectiveness of the RMMs without reducing its familiarity for patients and healthcare professionals using the concerned medicinal product.

Background

Revision 3 of Module XVI of the GVP Guideline describes risk minimization principles and control tools in more detail. Among other things, recommendations for a risk minimization within the benefit-risk management cycle of a medicinal product are given. Moreover, the guidance clarifies the relationship between routine and additional RMM tools and the resulting applicability for both of these RMM categories. Routine RMMs tools are included at the end of the document in Appendix 1. In addition, Appendix 2 provides educational / safety advice tools.

The revised Addendum II to GVP Module XVI on effectiveness evaluation provides additional guidance for authorization holders and authorities on data sources and methods for monitoring the effectiveness of RMMs.

Annex I - Definitions of the GVP modules was published in Revision 5. The document defines and describes a large number of terms in the area of pharmacovigilance. Among other things, text sections have now been updated and footnotes deleted that became obsolete due to the availability of the Clinical Trials Regulation (EU) No. 536/2014 (CTR). At the same time, terms from various GVP modules and guidance documents of the Committee for Medicinal Products for Human Use (CHMP) have been added.

To reflect these changes, the introductory cover note has also been updated to include reference to the revised Module XVI and Addendum II, and revision 5 of Annex I on definitions.

More information is available at EMA's Good pharmacovigilance practices (GVP) website.