GVP XVI Review: risk minimization updates

The revision of Module XVI of the Good Pharmacovigilance Practices (GVP) by the European Medicines Agency (EMA) represents a significant step forward in the regulation of pharmacovigilance in the European Union. Published on 26 July 2024 and coming into force on 6 August 2024, this third revision introduces important updates relating to Risk Minimisation Measures (RMM) and their management.

The revision of GVP XVI focuses on the integration of RMMs into the benefit-risk management cycle of medicinal products, providing detailed guidance on how these measures can be implemented, monitored and evaluated. The main aim is to make RMMs more effective by promoting robust evidence-based risk management.

The new guidance applies to three main areas:

• New marketing authorisations.
• New risk minimisation measures.
• New studies to assess the effectiveness of RMMs in already authorised medicines.

However, these guidelines do not apply immediately to existing RMMs or ongoing activities. If changes to existing measures are needed, it will be essential to take the review into account, especially if these changes can improve the effectiveness of RMMs without compromising patient and healthcare professional familiarity with the medicine.

A key element of the review is the introduction of Addendum II, which establishes new standards for assessing the effectiveness of RMMs. This document provides guidance on three key aspects:

• Data sources: the use of standardized databases and registries is suggested to ensure the quality and consistency of analyses.
• Research methodologies: structured approaches, such as observational studies and advanced statistical methods, are recommended to assess the measures adopted.
• Reporting: greater transparency and standardization in the presentation of the results of effectiveness studies is promoted.

Pharmaceutical companies are called upon to rapidly adapt to these new guidelines, integrating them into their risk management plans (RMPs). In particular, they must adopt a more structured approach to planning and continuous evaluation of RMMs, ensuring that the measures adopted are effective and evidence-based. This not only ensures compliance with regulatory requirements, but also strengthens patient safety and the effectiveness of managing risks associated with medicinal products.